NA 02.211.016Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10886982053596), received between Dec 12, 2017 and Nov 13, 2024 — classified as 22 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

7 other recalls cover devices cleared under the same FDA submission (K100776, K103243); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE 02.211.0XX 2.7MM VA LOCKING SCREWS WOULD NOT LOCK INTO THE CENTRAL POSTERIOR/ DISTAL HOLE OF THE 02.118.405 LEFT 5 HOLE VA DISTAL FIBULA PLATE. THE PROPER DRILL GUIDE AND TECHNIQUE WAS USED, BUT THE SCREW WOULD NOT LOCK NO MATTER WHAT THE SURGEON TRIED. SEVERAL ATTEMPTS AND DIFFERENT SCREWS WERE USED WITHOUT SUCCESS. THE SURGEON REMOVED THE PLATE AND SWITCHED TO A DIFFERENT PLATE, 02.118.407 AND THE SAME SCREW HOLE WOULD NOT LOCK. THE SURGEON LEFT THE HOLE EMPTY AND COMPLETED THE CASE. THERE WAS A SURGICAL DELAY WHILE PLATE WAS EXCHANGED, AND ALTERNATE SCREWS ATTEMPTED. PROBABLY 15 MIN DELAY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 20676032 ↗
• MalfunctionAug 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THE SURGERY WAS FINISHED WITH THE PLATE THAT WAS IMPLANTED. THE SCREW WAS DISCARDED. THE SURGERY WAS FINISHED WITH NO IMPACT ON PATIENT OR QUALITY OF FIXATION. THERE WILL BE NO NEED FOR REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666290 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE REMOVAL OF HARDWARE AND REVISION OF PATELLA WAS PERFORMED DUE TO NONUNION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 4 OF 7 FOR COMPLAINT: (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15675613 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON SEPTEMBER 13, REMOVAL OF HARDWARE AND REVISION OF PATELLA DUE TO NONUNION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 16. THIS IS REPORT 1 OF 3 FOR COMPLAINT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15561911 ↗
• MalfunctionJul 21, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE LOCKING SCREW IN QUESTION WAS BEING PUT INTO AN OLECRANON PLATE, AND THE SCREW WOULD NOT TIGHTEN INTO THE VA LOCKING HOLE. IT STRIPPED OUT. THE SCREW WAS VITAL, SO THE PROCEDURE WAS CONTINUED USING ANOTHER SCREW AND PLATE WITH NO DELAY. THERE WAS NO ADVERSE PATIENT OUTCOME, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15078482 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON OR ABOUT (B)(6) 2019 THE PATIENT HAD OPEN REDUCTION ULNAR FRACTURE PROXIMAL END WITH INTERNAL FIXATION OF HIS RIGHT ELBOW. ON OR ABOUT (B)(6) 2020 PATIENT WAS ADMITTED AND HAD AN INCISION, DRAINAGE, AND TREATMENT FOR INFECTION FROM HIS SURGICAL SITE. ON OR ABOUT (B)(6) 2021, THE PATIENT'S INFECTED HARDWARE WAS REMOVED FROM HIS BODY. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 16. THIS IS REPORT 9 OF 10 FOR COMPLAINT. PRODUCT COMPLAINT (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 12860721 ↗
• InjurySep 22, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE PROCEDURE THE DRIVING CAP DOES NOT LOCK INTO THE INSERTION HANDLE PROPERLY. THIS OCCURRED ON THE FIRST USAGE OF THE INSTRUMENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1)1.5MM DRILL BIT/QC/110MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12513280 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT THE HARDWARE REMOVAL, IRRIGATION AND DEBRIDEMENT DUE TO INFECTION AND COMPLETE FRACTURE UNION. A VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) 5 HOLE DISTAL FIBULA PLATE WAS IMPLANTED 6 MONTHS PRIOR TO TREAT THE DISTAL FIBULA FRACTURE. UPON INCISION THE SURGEON OBSERVED SIGNS OF INFECTION. WHEN THE SURGEON REMOVED THE 6 DISTAL 2.7 VA LOCKING SCREWS, ALL 6 WERE BROKEN OFF AT THE SCREW SHAFT/HEAD JUNCTION. ONLY THE LOCKING HEADS WERE REMOVED BY THE SCREWDRIVER. THE DOCTOR REMOVED THE SCREWS IN THE SHAFT WITHOUT INCIDENT AND THE PLATE WAS REMOVED. UPON COMPLETION OF THIS, THE SURGEON USED A HEAVY NEEDLE DRIVER TO UNSCREW AND REMOVED ALL 6 BROKEN SCREW SHAFTS WITH MINIMAL ADDITION OF TIME TO THE SURGERY. THE SURGEON DID NOT SUSPECT THAT THE HARDWARE WAS BROKEN PRIOR TO THE REMOVAL SURGERY. PER SURGEON THE FRACTURE WAS WELL HEALED AFTER REMOVING THE PLATE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11592402 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT THE HARDWARE REMOVAL, IRRIGATION AND DEBRIDEMENT DUE TO INFECTION AND COMPLETE FRACTURE UNION. A VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) 5 HOLE DISTAL FIBULA PLATE WAS IMPLANTED 6 MONTHS PRIOR TO TREAT THE DISTAL FIBULA FRACTURE. UPON INCISION THE SURGEON OBSERVED SIGNS OF INFECTION. WHEN THE SURGEON REMOVED THE 6 DISTAL 2.7 VA LOCKING SCREWS, ALL 6 WERE BROKEN OFF AT THE SCREW SHAFT/HEAD JUNCTION. ONLY THE LOCKING HEADS WERE REMOVED BY THE SCREWDRIVER. THE DOCTOR REMOVED THE SCREWS IN THE SHAFT WITHOUT INCIDENT AND THE PLATE WAS REMOVED. UPON COMPLETION OF THIS, THE SURGEON USED A HEAVY NEEDLE DRIVER TO UNSCREW AND REMOVED ALL 6 BROKEN SCREW SHAFTS WITH MINIMAL ADDITION OF TIME TO THE SURGERY. THE SURGEON DID NOT SUSPECT THAT THE HARDWARE WAS BROKEN PRIOR TO THE REMOVAL SURGERY. PER SURGEON THE FRACTURE WAS WELL HEALED AFTER REMOVING THE PLATE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11592401 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT THE HARDWARE REMOVAL, IRRIGATION AND DEBRIDEMENT DUE TO INFECTION AND COMPLETE FRACTURE UNION. A VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) 5 HOLE DISTAL FIBULA PLATE WAS IMPLANTED 6 MONTHS PRIOR TO TREAT THE DISTAL FIBULA FRACTURE. UPON INCISION THE SURGEON OBSERVED SIGNS OF INFECTION. WHEN THE SURGEON REMOVED THE 6 DISTAL 2.7 VA LOCKING SCREWS, ALL 6 WERE BROKEN OFF AT THE SCREW SHAFT/HEAD JUNCTION. ONLY THE LOCKING HEADS WERE REMOVED BY THE SCREWDRIVER. THE DOCTOR REMOVED THE SCREWS IN THE SHAFT WITHOUT INCIDENT AND THE PLATE WAS REMOVED. UPON COMPLETION OF THIS, THE SURGEON USED A HEAVY NEEDLE DRIVER TO UNSCREW AND REMOVED ALL 6 BROKEN SCREW SHAFTS WITH MINIMAL ADDITION OF TIME TO THE SURGERY. THE SURGEON DID NOT SUSPECT THAT THE HARDWARE WAS BROKEN PRIOR TO THE REMOVAL SURGERY. PER SURGEON THE FRACTURE WAS WELL HEALED AFTER REMOVING THE PLATE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.7MM VA LACKING SCREW SLF-TYPING WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11592319 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT THE HARDWARE REMOVAL, IRRIGATION AND DEBRIDEMENT DUE TO INFECTION AND COMPLETE FRACTURE UNION. A VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) 5 HOLE DISTAL FIBULA PLATE WAS IMPLANTED 6 MONTHS PRIOR TO TREAT THE DISTAL FIBULA FRACTURE. UPON INCISION THE SURGEON OBSERVED SIGNS OF INFECTION. WHEN THE SURGEON REMOVED THE 6 DISTAL 2.7 VA LOCKING SCREWS, ALL 6 WERE BROKEN OFF AT THE SCREW SHAFT/ HEAD JUNCTION. ONLY THE LOCKING HEADS WERE REMOVED BY THE SCREWDRIVER. THE DOCTOR REMOVED THE SCREWS IN THE SHAFT WITHOUT INCIDENT AND THE PLATE WAS REMOVED. UPON COMPLETION OF THIS, THE SURGEON USED A HEAVY NEEDLE DRIVER TO UNSCREW AND REMOVED ALL 6 BROKEN SCREW SHAFTS WITH MINIMAL ADDITION OF TIME TO THE SURGERY. THE SURGEON DID NOT SUSPECT THAT THE HARDWARE WAS BROKEN PRIOR TO THE REMOVAL SURGERY. PER SURGEON THE FRACTURE WAS WELL HEALED AFTER REMOVING THE PLATE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11592309 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT THE HARDWARE REMOVAL, IRRIGATION AND DEBRIDEMENT DUE TO INFECTION AND COMPLETE FRACTURE UNION. A VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) 5 HOLE DISTAL FIBULA PLATE WAS IMPLANTED 6 MONTHS PRIOR TO TREAT THE DISTAL FIBULA FRACTURE. UPON INCISION THE SURGEON OBSERVED SIGNS OF INFECTION. WHEN THE SURGEON REMOVED THE 6 DISTAL 2.7 VA LOCKING SCREWS, ALL 6 WERE BROKEN OFF AT THE SCREW SHAFT/HEAD JUNCTION. ONLY THE LOCKING HEADS WERE REMOVED BY THE SCREWDRIVER. THE DOCTOR REMOVED THE SCREWS IN THE SHAFT WITHOUT INCIDENT AND THE PLATE WAS REMOVED. UPON COMPLETION OF THIS, THE SURGEON USED A HEAVY NEEDLE DRIVER TO UNSCREW AND REMOVED ALL 6 BROKEN SCREW SHAFTS WITH MINIMAL ADDITION OF TIME TO THE SURGERY. THE SURGEON DID NOT SUSPECT THAT THE HARDWARE WAS BROKEN PRIOR TO THE REMOVAL SURGERY. PER SURGEON THE FRACTURE WAS WELL HEALED AFTER REMOVING THE PLATE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11592287 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT THE HARDWARE REMOVAL, IRRIGATION AND DEBRIDEMENT DUE TO INFECTION AND COMPLETE FRACTURE UNION. A VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) 5 HOLE DISTAL FIBULA PLATE WAS IMPLANTED 6 MONTHS PRIOR TO TREAT THE DISTAL FIBULA FRACTURE. UPON INCISION THE SURGEON OBSERVED SIGNS OF INFECTION. WHEN THE SURGEON REMOVED THE 6 DISTAL 2.7 VA LOCKING SCREWS, ALL 6 WERE BROKEN OFF AT THE SCREW SHAFT/HEAD JUNCTION. ONLY THE LOCKING HEADS WERE REMOVED BY THE SCREWDRIVER. THE DOCTOR REMOVED THE SCREWS IN THE SHAFT WITHOUT INCIDENT AND THE PLATE WAS REMOVED. UPON COMPLETION OF THIS, THE SURGEON USED A HEAVY NEEDLE DRIVER TO UNSCREW AND REMOVED ALL 6 BROKEN SCREW SHAFTS WITH MINIMAL ADDITION OF TIME TO THE SURGERY. THE SURGEON DID NOT SUSPECT THAT THE HARDWARE WAS BROKEN PRIOR TO THE REMOVAL SURGERY. PER SURGEON THE FRACTURE WAS WELL HEALED AFTER REMOVING THE PLATE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11592284 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN SURGERY, LOCKING COMPRESSION PLATE, CORTEX SCREWS, AND LOCKING SCREWS WERE TAKEN OUT DUE TO PATIENT PAIN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.7MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 202.816, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1); 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM (PART NUMBER 02.112.048, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM (PART NUMBER 212.104, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 14MM (PART NUMBER 204.814, LOT UNKNOWN, QUANTITY 1); 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11164256 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN SURGERY, LOCKING COMPRESSION PLATE, CORTEX SCREWS, AND LOCKING SCREWS WERE TAKEN OUT DUE TO PATIENT PAIN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.7MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 202.816, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1), 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM (PART NUMBER 02.112.048, LOT UNKNOWN, QUANTITY 1), 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM (PART NUMBER 212.104, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 14MM (PART NUMBER 204.814, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11163558 ↗
• MalfunctionOct 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, TWO (2) OF THE VARIABLE ANGLE (VA) DISTAL LOCKING SCREWS DID NOT LOCK INTO THE VARIABLE ANGLE, LOCKING COMPRESSION PLATE (VA-LCP) DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE ANKLE. THE SCREWS WERE LEFT IN PLACE AND THERE IS NO PLAN FOR REVISION. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) 2.7 MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16 MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204025 ↗
• InjurySep 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE THE SURGEON WAS USING A VARIABLE ANGLE LATERAL DISTAL FIBULA PLATE AND PLACED A VARIABLE ANGLE THREADED DRILL GUIDE FROM THE UNIVERSAL SMALL FRAGMENT (USF) INTO THE PLATE AND DRILLED WITH A 2.0 DRILL BIT FOR 2.7 VARIABLE ANGLE LOCKING SCREWS, TWO (2) OF THE HOLES WOULD NOT LOCK AND THE SCREWS WOULD JUST SPIN IN THE LOCKING HOLE DURING OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE ANKLE. TOTAL 5 SCREWS WERE USED AND WOULD NOT LOCK. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A DIFFERENT 2.7/3.5 VARIABLE ANGLE LATERAL DISTAL FIBULA PLATE AND DIFFERENT SCREWS. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: GUIDE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNK - DRILL BITS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW 16MM. THIS IS REPORT 6 OF 6 FOR COMPLAINT.

  Patient problems: No Code Available

  MAUDE report 9072389 ↗
• InjurySep 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE THE SURGEON WAS USING A VARIABLE ANGLE LATERAL DISTAL FIBULA PLATE AND PLACED A VARIABLE ANGLE THREADED DRILL GUIDE FROM THE UNIVERSAL SMALL FRAGMENT (USF) INTO THE PLATE AND DRILLED WITH A 2.0 DRILL BIT FOR 2.7 VARIABLE ANGLE LOCKING SCREWS, TWO (2) OF THE HOLES WOULD NOT LOCK AND THE SCREWS WOULD JUST SPIN IN THE LOCKING HOLE DURING OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE ANKLE. TOTAL 5 SCREWS WERE USED AND WOULD NOT LOCK. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A DIFFERENT 2.7/3.5 VARIABLE ANGLE LATERAL DISTAL FIBULA PLATE AND DIFFERENT SCREWS. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: GUIDE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNK - DRILL BITS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW 16MM. THIS IS REPORT 4 OF 6 FOR COMPLAINT.

  Patient problems: No Code Available

  MAUDE report 9072330 ↗
• MalfunctionAug 8, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INCOMING RECEIPT OF A REPLENISHMENT ORDER, THE BAG FOR THE VARIABLE ANGLE LOCKING SCREW SELF-TAPING WAS OBSERVED TO BE EMPTY WHEN THERE SHOULD HAVE BEEN ONE PART IN THE BAG. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A VARIABLE ANGLE LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8875180 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF PAINFUL HARDWARE PROXIMAL ASPECT OF RIGHT ULNA. ON (B)(6) 2014, THE PATIENT SUSTAINED AN INJURY AFTER TRIPPING AND FALLING FROM A STANDING POSITION AND LANDED DIRECTLY INTO THE RIGHT ELBOW. THE PATIENT HAD THE ONSET OF PAIN AND INABILITY TO FULLY USE THE ELBOW. SUBSEQUENT X-RAYS WERE TAKEN AND REVEALED A DISPLACED, DISTRACTED OLECRANON FRACTURE, WITH A COMMINUTED RIGHT RADIAL HEAD FRACTURE. THE PATIENT ALSO COMPLAINS OF PAIN IN THE RIGHT PROXIMAL HUMERUS. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2014 WITH ONE (1) VARIABLE ANGLE ¿ LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 24MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM, ONE (1) LOCKING SCREW SELF-TAPPING WITH STARD

  Patient problems: Bone Fracture(s); Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8692265 ↗
• InjuryJun 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE EXTENDED MEDIAL DISTAL HUMERUS PLATES, ONE (1) CORTEX SCREW SELF-TAPPING 50MM, ONE (1) CORTEX SCREW SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 24MM, THREE (3) CORTEX SCREWS SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 22MM, ONE (1) CORTEX SCREW SELF-TAPPING 26MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM AND ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM. SOME SCREWS WERE BROKEN AND LEFT. OTHER SCREWS WERE LEFT IN THE BODY. IT IS UNKNOWN IF WHAT SCREWS WERE LEFT/BROKEN. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. P

  Patient problems: Pain

  MAUDE report 8684332 ↗
• MalfunctionJun 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THREE (3) LOCKING SCREWS WERE NOT LOCKING IN. THE VARIABLE ANGLE DISTAL FIBULA PLATE WAS ALSO USED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SCREWS STILL IMPLANTED IN THE PATIENT. CONCOMITANT DEVICES REPORTED: 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/6 HOLES/LEFT (PART# 02.118.407, LOT# UNKNOWN, QUANTITY# 1. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8670603 ↗
• InjuryDec 10, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT A PROCEDURE. DURING THE PROCEDURE, TWO (2) LOCKING SCREWS WOULD NOT LOCK IN THE SPECIFIC SCREW HOLES OF THE PLATE. THE SURGEON HAD TO JUST LEAVE THAT HOLE WITHOUT THE LOCKING SCREWS IN IT. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THREE (3) MINUTES DELAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR ONE (1) VA LOCKING SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8147130 ↗
• InjuryNov 29, 2018Device Slipped; Device Slipped

  THERE ARE THREE (3) CORTEX SCREWS.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8115486 ↗
• InjuryNov 29, 2018Device Slipped; Device Slipped

  IT WAS NOTED THAT AT THE TIME OF THE REVISION PROCEDURE, THE CLAVICLE FRACTURE WAS NOT HEALED.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8115439 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100776, K103243. One submission often covers many models, so check the product and lot details in each record.

• Z-0880-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0883-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0882-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0879-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0881-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag