NA 02.211.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982053695), received between Oct 18, 2018 and Dec 24, 2025 — classified as 11 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 reports).

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SEVERAL DEVICES WERE STRIPPED AND/OR BENT AND SOME SCREWS WOULD NOT LOCK IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889179 ↗
• MalfunctionJan 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE DISTAL RADIUS CASE, DON¿T KNOW IF THE SCREW OR PLATE VA HOLE STRIPPED, BOTH WERE REPLACED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21181042 ↗
• MalfunctionDec 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, AN ORIF ANKLE PROCEDURE WAS BEING PERFORMED. DURING THE PROCEDURE, THE SURGEON HAD DIFFICULTY LOCKING INTO THE DISTAL PORTION OF THE VA-LCP POSTERIOR DISTAL T PLATE. THIS CAUSED AN UNKNOWN SURGICAL DELAY AND REQUIRED ADDITIONAL X-RAYS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER PLATE AND DIFFERENT SIZED SCREWS. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 36MM. THIS IS REPORT 4 OF 4 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329166 ↗
• MalfunctionDec 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 20-NOVEMBER-2023, AN ORIF ANKLE PROCEDURE WAS BEING PERFORMED. DURING THE PROCEDURE, THE SURGEON HAD DIFFICULTY LOCKING INTO THE DISTAL PORTION OF THE VA-LCP POSTERIOR DISTAL T PLATE. THIS CAUSED AN UNKNOWN SURGICAL DELAY AND REQUIRED ADDITIONAL X-RAYS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER PLATE AND DIFFERENT SIZED SCREWS. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 36MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329106 ↗
• MalfunctionDec 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, AN ORIF ANKLE PROCEDURE WAS BEING PERFORMED. DURING THE PROCEDURE, THE SURGEON HAD DIFFICULTY LOCKING INTO THE DISTAL PORTION OF THE VA-LCP POSTERIOR DISTAL T PLATE. THIS CAUSED AN UNKNOWN SURGICAL DELAY AND REQUIRED ADDITIONAL X-RAYS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER PLATE AND DIFFERENT SIZED SCREWS. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 36MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329104 ↗
• InjuryJul 8, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THERE WAS LACK OF LOCKING OF 2.7 MM LOCKING SCREWS IN TWO (2) LOW COMPRESSION PLATE (LCP) ELBOW PLATES WITH A DYNAMOMETRIC SCREWDRIVER INTRAOPERATIVELY. SEVERAL SCREWS BENT AND THERE WERE TWO (2) EDGES ON ONE SIDE. THE PATIENT WAS IMMOBILIZED FOR TEN (10) DAYS AND X-RAYS WERE TAKEN. A SURGICAL REVISION IS PLANNED TO REMOVE EVERYTHING BUT HAS NOT YET BEEN COMPLETED. IMPLANTS ARE STILL CURRENTLY IMPLANTED IN THE PATIENT. THIS IS REPORT 6 OF 12 FOR (B)(4). THIS REPORT IS FOR A LOCKING SCREW.

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

  MAUDE report 14959865 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF VARIABLE ANGLE MEDIAL TIBIA PLATE AND CORRESPONDING SCREWS DUE TO NONUNION. THE MEDIAL PLATE WAS ORIGINALLY PUT ON THE LATERAL SIDE OF THE PATIENTS TIBIA. SURGEON REMOVED ALL HARDWARE, CREATED AN OSTEOTOMY, THEN PUT IN A ZIMMER HINDFOOT NAIL AS WELL AS SYNTHES VA PROXIMAL TIBIA PLATE. PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36. THIS IS REPORT 11 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13388604 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF VARIABLE ANGLE MEDIAL TIBIA PLATE AND CORRESPONDING SCREWS DUE TO NONUNION. THE MEDIAL PLATE WAS ORIGINALLY PUT ON THE LATERAL SIDE OF THE PATIENTS TIBIA. SURGEON REMOVED ALL HARDWARE, CREATED AN OSTEOTOMY, THEN PUT IN A ZIMMER HINDFOOT NAIL AS WELL AS SYNTHES VA PROXIMAL TIBIA PLATE. PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36. THIS IS REPORT 8 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13388582 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF VARIABLE ANGLE MEDIAL TIBIA PLATE AND CORRESPONDING SCREWS DUE TO NONUNION. THE MEDIAL PLATE WAS ORIGINALLY PUT ON THE LATERAL SIDE OF THE PATIENTS TIBIA. SURGEON REMOVED ALL HARDWARE, CREATED AN OSTEOTOMY, THEN PUT IN A ZIMMER HINDFOOT NAIL AS WELL AS SYNTHES VA PROXIMAL TIBIA PLATE. PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36. THIS IS REPORT 9 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13388559 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF VARIABLE ANGLE MEDIAL TIBIA PLATE AND CORRESPONDING SCREWS DUE TO NONUNION. THE MEDIAL PLATE WAS ORIGINALLY PUT ON THE LATERAL SIDE OF THE PATIENTS TIBIA. SURGEON REMOVED ALL HARDWARE, CREATED AN OSTEOTOMY, THEN PUT IN A ZIMMER HINDFOOT NAIL AS WELL AS SYNTHES VA PROXIMAL TIBIA PLATE. PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36. THIS IS REPORT 6 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13388522 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF VARIABLE ANGLE MEDIAL TIBIA PLATE AND CORRESPONDING SCREWS DUE TO NONUNION. THE MEDIAL PLATE WAS ORIGINALLY PUT ON THE LATERAL SIDE OF THE PATIENTS TIBIA. SURGEON REMOVED ALL HARDWARE, CREATED AN OSTEOTOMY, THEN PUT IN A ZIMMER HINDFOOT NAIL AS WELL AS SYNTHES VA PROXIMAL TIBIA PLATE. PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36. THIS IS REPORT 2 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13388492 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF VARIABLE ANGLE MEDIAL TIBIA PLATE AND CORRESPONDING SCREWS DUE TO NONUNION. THE MEDIAL PLATE WAS ORIGINALLY PUT ON THE LATERAL SIDE OF THE PATIENTS TIBIA. SURGEON REMOVED ALL HARDWARE, CREATED AN OSTEOTOMY, THEN PUT IN A ZIMMER HINDFOOT NAIL AS WELL AS SYNTHES VA PROXIMAL TIBIA PLATE. PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36. THIS IS REPORT 5 OF 14 FOR COMPLAINT (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13388412 ↗
• MalfunctionJul 23, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.7MM LOCKING SCREW AND 2.4 MM VA LOCKING SCREW WERE RECEIVED ON EMPTY SEALED PACKAGE. EACH OF THESE DEVICES WAS PROVIDED AS PART OF FIELD INVENTORY REPLENISHMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217331 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED ON (B)(6) 2020, THAT PATIENT UNDERWENT REVISION SURGERY DUE TO NONUNION AND 1 BROKEN 60MM LENGTH VA LOCKING SCREW. ONE (1) VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, SEVEN (7) VA LOCKING SCREWS AND ONE (1) CORTEX SCREW AND ONE (1) VA LCP DISTAL HUMERUS PLATE WERE SUCCESSFULLY EXPLANTED. THERE WAS A FRAGMENT OF THE SHAFT AND THE SCREWHEAD BUT IT WAS REMOVED EASILY WITHOUT ADDED TIME. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES.

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

  MAUDE report 10752399 ↗
• MalfunctionSep 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE THE THREE (3) LOCKING SCREWS WOULD NOT LOCK INTO THE VARIABLE ANGLE DISTAL HUMERUS PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10553477 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO LEFT ELBOW MONTEGGIA FRACTURE DISLOCATION WITH ULNAR NONUNION, STATUS POST BONE GRAFTING WITH NOW PAINFUL DEEP HARDWARE, POSSIBLE DELAYED UNION, AS WELL AS ULNAR NERVE COMPRESSION. ON (B)(6) 2017, THE PATIENT UNDERWENT A SURGERY AND WAS DIAGNOSED WITH NONUNION LEFT PROXIMAL ULNA STATUS POST OPEN REDUCTION INTERNAL FIXATION MONTEGGIA FRACTURE SUBLUXATION AND WAS IMPLANTED WITH A SYNTHES PLATE AND SCREWS. CONCOMITANT DEVICES REPORTED: 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM (PART NUMBER 02.107.304, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/28MM (PART NUMBER 02.118.528, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM (PART NUMBER 02.211.024, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM (PART NUMBER 02.211.040, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.7MM VA LCK SCREW SLF-TAP. THIS IS REPORT 4 OF 5 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), CAPTURES THE REMAINING FIVE (5) OUT OF FIFTEEN (15) DEVICES. (B)(4) CAPTURES THE FIRST TEN (10) DEVICES OF THE THIRD REVISION. (B)(4

  Patient problems: Bone Fracture(s); Nerve Damage; No Code Available; Pain

  MAUDE report 10441946 ↗
• MalfunctionOct 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE, THREE (3) VARIABLE ANGLE (VA) LOCKING SCREWS WOULD NOT LOCK INTO FOUR DIFFERENT SCREW HOLES OF THE VA LOCKING COMPRESSION PLATE (LCP) OLECRANON PLATE. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 36MM. THIS IS REPORT 3 OF 4 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9178999 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018, DUE TO A NONUNION AND HARDWARE FAILURE. PATIENT INITIALLY HAD AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY ON (B)(6) 2018, TO TREAT A LEFT DISTAL HUMERUS FRACTURE. THE IMPLANTED DEVICES WERE VARIABLE ANGLE DISTAL HUMERUS PLATE, VARIABLE ANGLE-LCP LAT DISTAL HUMERUS PLATE, EIGHT (8) VARIABLE ANGLE LOCKING SCREW SELF-TPING WITH T8 STARDRIVE, VARIABLE ANGLE LOCKING SCREW SELF-TPING WITH T8 STARDRIVE, VARIABLE ANGLE-LCP PROXIMAL OLECRANON, AND FOUR (4) ORTEX SCREW SELF- TAPPING. THE PROCEDURE WAS COMPLETED, AND ALL HARDWARE WAS REMOVED INTACT. THE FRACTURE WAS REDUCED, AND AN UNKNOWN VARIABLE ANGLE ELBOW PLATE WITH UNKNOWN SCREWS WERE USED FOR FIXATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS STABLE. THIS REPORT IS FOR ONE (1) 2.7 MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 36 MM THIS IS REPORT 6 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8129244 ↗
• MalfunctionNov 9, 2018Crack; Crack

  (B)(6) REPORTS FOLLOWING: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE SURGEON WAS USING THE VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) OLECRANON PLATE AND THE ISSUE WAS OBSERVED DURING THE INSERTION OF A 2.7MM VA LOCKING SCREW. THE SURGEON NOTICED THAT THE THREAD OF THE SCREW WAS PEELING OFF THE CORE OF THE SCREW WHILE THE SCREW WAS ADVANCING IN THE BONE. THE SURGEON CLAIMS THAT THE CONE GUIDE WAS INSERTED PROPERLY AND THE TORQUE LIMITING ATTACHMENT (TLA) WAS USED AS WELL. THE PEELED SCREW WAS THEN REMOVED AND DISCARDED. THEY USED A DIFFERENT SCREW AND THE ISSUE DIDN'T REPEAT ITSELF. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT HARM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES: CONE GUIDE (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), TORQUE LIMITING ATTACHMENT (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), VA-LCP PROXIMAL OLECRANON PLATE (PART 02.107.304, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8056612 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO PAIN ON (B)(6) 2018. HARDWARE REMOVED DURING THE PROCEDURE INVOLVES ONE (1) LOCKING COMPRESSION PLATE (LCP) ONE-THIRD TUBULAR PLATE WITH COLLAR, ONE (1) VARIABLE ANGLE LCP MEDIAL DISTAL TIBIA PLATE, SEVEN (7) CORTEX SCREWS, TWO (2) LOCKING SCREWS WITH STARDRIVE AND FIVE (5) VARIABLE ANGLE LOCKING SCREWS WITH T8 STARDRIVE. THE HARDWARE WAS IMPLANTED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS BROKE. THE BROKEN SCREWS WERE FULLY REMOVED. THE BONE WAS HEALED AND NO ADDITIONAL HARDWARE WAS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT ADDRESSES THE REVISION SURGERY DUE TO PAIN. ADDITIONAL PRODUCTS INVOLVED ARE ADDRESSED IN (B)(4). THE INTRAOPERATIVE ISSUE WITH THE BROKEN SCREWS IS ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7978538 ↗
• MalfunctionOct 18, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. DURING THE PROCEDURE, FIVE (5) VARIABLE ANGLE (VA) LOCKING SCREWS WERE BROKEN. THE BROKEN SCREWS WERE FULLY REMOVED. THE BONE WAS HEALED. NO ADDITIONAL HARDWARE WAS PLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. REVISION SURGERY DUE TO PAIN IS ADDRESSED IN (B)(4). THIS REPORT ADDRESSES THE INTRAOPERATIVE ISSUE WITH BROKEN SCREWS. CONCOMITANT DEVICES: 3.5MM CORTEX SCREW 22MM (PART 204.822, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW 24MM (PART 204.824, LOT UNKNOWN, QUANTITY 2), 3.5MM CORTEX SCREW 30MM (PART 204.830, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW 16MM (PART 204.816, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW 12MM (PART 204.812, LOT UNKNOWN, QUANTITY 2), 3.5MM LOCKING SCREW 10MM (PART 212.101, LOT UNKNOWN, QUANTITY 1), 3.5MM LOCKING SCREW 14MM (PART 212.103, LOT UNKNOWN, QUANTITY 1), LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 69MM (PART 241.361, LOT H398866, QUANTITY 1), 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE-RIGHT (PART 02.118.004, LOT 9512579, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7977668 ↗