NA 201.768Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982142771), received between Oct 19, 2018 and Jul 17, 2020 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 reports).

10 other recalls cover devices cleared under the same FDA submission (K002271, K063049, K102694, K103243, K112583); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL RADIUS SYSTEM IMPLANTATION, WHILE INSERTING AN UNKNOWN VOLAR VARIABLE ANGLE (VA) PLATE, THE SURGEON WAS USING A GUIDE BLOCK ON THE UNKNOWN PLATE. THE SURGEON PREFERRED INSERTING PROVISIONAL 2.4MM CORTEX SCREWS IN THE DISTAL PORTION OF THE UNKNOWN PLATE THROUGH THE GUIDE BLOCK. HOWEVER, TWO (2) OF THE CORTEX SCREWS WOULD NOT FIT THROUGH THE GUIDE BLOCK. ONE OF THEM DID. THE SURGEON UNDERSTOOD THAT THE UNKNOWN VARIABLE ANGLE (VA) LOCKING SCREWS ARE TO BE USED IN THE DISTAL PORTION, CORTEX SCREWS HAVE BEEN USED IN THE PAST TO COMPRESS THE UNKNOWN PLATE PROVISIONALLY BEFORE REPLACING WITH AN UNKNOWN VA VARIABLE ANGLE (VA) LOCKING SCREWS. THE SURGEON INSERTED AN UNKNOWN VARIABLE ANGLE (VA) LOCKING SCREWS INSTEAD OF A CORTEX SCREWS. THE ISSUE WAS THAT THE 2.4MM CORTEX SCREWS HEADS ARE DIFFERENT DIAMETERS AND SOME WOULD NOT FIT THROUGH THE GUIDE BLOCK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), GUIDE BLOCK FOR 2 COLUMN PLATE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289949 ↗
• MalfunctionJul 17, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL RADIUS SYSTEM IMPLANTATION, WHILE INSERTING AN UNKNOWN VOLAR VARIABLE ANGLE (VA) PLATE, THE SURGEON WAS USING A GUIDE BLOCK ON THE UNKNOWN PLATE. THE SURGEON PREFERRED INSERTING PROVISIONAL 2.4MM CORTEX SCREWS IN THE DISTAL PORTION OF THE UNKNOWN PLATE THROUGH THE GUIDE BLOCK. HOWEVER, TWO (2) OF THE CORTEX SCREWS WOULD NOT FIT THROUGH THE GUIDE BLOCK. ONE OF THEM DID. THE SURGEON UNDERSTOOD THAT THE UNKNOWN VARIABLE ANGLE (VA) LOCKING SCREWS ARE TO BE USED IN THE DISTAL PORTION, CORTEX SCREWS HAVE BEEN USED IN THE PAST TO COMPRESS THE UNKNOWN PLATE PROVISIONALLY BEFORE REPLACING WITH AN UNKNOWN VA VARIABLE ANGLE (VA) LOCKING SCREWS. THE SURGEON INSERTED AN UNKNOWN VARIABLE ANGLE (VA) LOCKING SCREWS INSTEAD OF A CORTEX SCREWS. THE ISSUE WAS THAT THE 2.4MM CORTEX SCREWS HEADS ARE DIFFERENT DIAMETERS AND SOME WOULD NOT FIT THROUGH THE GUIDE BLOCK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: PLATE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), GUIDE BLOCK FOR 2 COLUMN PLATE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289914 ↗
• InjuryOct 28, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ON A DISTAL RADIUS SURGERY, THE SURGEON ATTEMPTED TO INSERT A ONE (1) CORTEX SCREW SELF-TAPPING WITH STARDRIVE RECESS THROUGH A , ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE ON, A ONE (1) VARIABLE ANGLE (VA) NARROW TWO-COLUMN VOLAR DISTAL RADIUS PLATE. THE CORTEX SCREW WOULD NOT FIT THROUGH THE GUIDE BLOCK AND PROCEEDED TO TEST OUT TWO (2) ADDITIONAL CORTEX SCREW ON THE BACK TABLE THROUGH A SEPARATE GUIDE BLOCK AND WAS UNSUCCESSFUL, A VA LOCKING SCREW WAS USED INSTEAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: VARIABLE ANGLE (VA) NARROW TWO-COLUMN VOLAR DISTAL RADIUS PLATE (PART #: 02.111.531 LOT #: UNKNOWN, QUANTITY #: 1). THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9243704 ↗
• InjuryOct 25, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ON A DISTAL RADIUS SURGERY, THE SURGEON ATTEMPTED TO INSERT A ONE (1) CORTEX SCREW SELF-TAPPING WITH STARDRIVE RECESS THROUGH A, ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE ON, A ONE (1) VARIABLE ANGLE (VA) NARROW TWO-COLUMN VOLAR DISTAL RADIUS PLATE. THE CORTEX SCREW WOULD NOT FIT THROUGH THE GUIDE BLOCK AND PROCEEDED TO TEST OUT TWO (2) ADDITIONAL CORTEX SCREW ON THE BACK TABLE THROUGH A SEPARATE GUIDE BLOCK AND WAS UNSUCCESSFUL, A VA LOCKING SCREW WAS USED INSTEAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: VARIABLE ANGLE (VA) NARROW TWO-COLUMN VOLAR DISTAL RADIUS PLATE (PART #: 02.111.531, LOT #: UNKNOWN, QUANTITY #: 1). THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9240737 ↗
• InjuryOct 25, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ON A DISTAL RADIUS SURGERY, THE SURGEON ATTEMPTED TO INSERT A ONE (1) CORTEX SCREW SELF-TAPPING WITH STARDRIVE RECESS THROUGH A , ONE (1) GUIDE BLOCK FOR TWO-COLUMN PLATE ON, A ONE (1) VARIABLE ANGLE (VA) NARROW TWO-COLUMN VOLAR DISTAL RADIUS PLATE. THE CORTEX SCREW WOULD NOT FIT THROUGH THE GUIDE BLOCK AND PROCEEDED TO TEST OUT TWO (2) ADDITIONAL CORTEX SCREW ON THE BACK TABLE THROUGH A SEPARATE GUIDE BLOCK AND WAS UNSUCCESSFUL, A VA LOCKING SCREW WAS USED INSTEAD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: VARIABLE ANGLE (VA) NARROW TWO-COLUMN VOLAR DISTAL RADIUS PLATE (PART #: 02.111.531 LOT #: UNKNOWN, QUANTITY #: 1). THIS COMPLAINT INVOLVES ONE (1) 2.4MM CORTEX SCREW SELF-TAPING WITH T8 STARDRIVE RECESS 18MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9240713 ↗
• MalfunctionMay 21, 2019Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2019, A CORTEX SCREWS SITTING THROUGH THE GUIDE BLOCK FOR A VARIABLE ANGLE 2.4 LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS PLATE. A CORTICAL SCREW HEAD DID NOT FIT TO THE GUIDE BLOCK. ANOTHER EXACT SAME SCREW WAS PULLED OUT AND IT DID FIT THROUGH THE GUIDE BLOCK. THERE WAS A SURGICAL DELAY OF APPROXIMATELY THIRTY SECONDS AS THE SCRUB TECH LOCATED THE SAME SCREW THAT FIT THROUGH THE GUIDE BLOCK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS EXCELLENT. CONCOMITANT DEVICE: GUIDE BLOCK (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1)  2.4 VARIABLE ANGLE 2.4 LOCKING COMPRESSION PLATE DISTAL RADIUS PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).  THIS REPORT IS FOR ONE (1) CORTEX SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8629405 ↗
• MalfunctionMay 3, 2019Fitting Problem; Device-Device Incompatibility; Device Difficult to Maintain; Fitting Problem; Device-Device Incompatibility; Device Difficult to Maintain

  IT WAS REPORTED THAT ON (B)(6) 2019, A 3 HOLE SHAFT VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS TWO COLUMN 6HH NARROW WAS USED. THE SURGEON ATTEMPTED TO INSERT ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM THROUGH THE 6 HOLE GUIDING BLOCK. THE SCREW WOULD NOT FIT THROUGH THE GUIDE. OTHER SCREWS WERE TRIED. TWO (2) ADDITIONAL CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM WOULD NOT FIT THROUGH THE GUIDE AND FINALLY ONE DID. THERE WAS A 5 MINUTES SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NOT AFFECTED. CONCOMITANT DEVICE REPORTED: 3 HOLE SHAFT VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) (PART #UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IF FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8580051 ↗
• MalfunctionMay 3, 2019Fitting Problem; Device-Device Incompatibility; Device Difficult to Maintain; Fitting Problem; Device-Device Incompatibility; Device Difficult to Maintain

  IT WAS REPORTED THAT ON (B)(6) 2019, A 3 HOLE SHAFT VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS TWO COLUMN 6HH NARROW WAS USED. THE SURGEON ATTEMPTED TO INSERT ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM THROUGH THE 6 HOLE GUIDING BLOCK. THE SCREW WOULD NOT FIT THROUGH THE GUIDE. OTHER SCREWS WERE TRIED. TWO (2) ADDITIONAL CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM WOULD NOT FIT THROUGH THE GUIDE AND FINALLY ONE DID. THERE WAS A 5 MINUTES SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NOT AFFECTED. CONCOMITANT DEVICE REPORTED: 3 HOLE SHAFT VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) (PART #UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IF FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8580050 ↗
• MalfunctionMay 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, POST-OPERATIVE, THE SCRUB NOTED FOLLOWING ON THE BACK TABLE: ONE (1) CORTEX SCREW 18MM BECAME INCARCERATED IN THE GUIDE BLOCK. ADDITIONALLY, THREE (3) CORTEX SCREWS 12MM, THREE (3) CORTEX SCREWS 14MM, ONE (1) CORTEX SCREW 16MM THREE (3) CORTEX SCREWS 18MM, ONE (1) CORTEX SCREW 22MM, TWO (2) CORTEX SCREW 24MM, AND ONE (1) CORTEX SCREW 28MM WOULD NOT FIT THROUGH THE GUIDE BLOCK. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 16 DEVICES DUE TO THE SYSTEM LIMITATION, THIS INCIDENT WILL BE CAPTURED UNDER THIS (B)(4) (10 DEVICES) AND LINKED (B)(4) (6 DEVICES). THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW 18MM. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579528 ↗
• MalfunctionMay 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, POST-OPERATIVE, THE SCRUB NOTED FOLLOWING ON THE BACK TABLE: ONE (1) CORTEX SCREW 18MM BECAME INCARCERATED IN THE GUIDE BLOCK. ADDITIONALLY, THREE (3) CORTEX SCREWS 12MM, THREE (3) CORTEX SCREWS 14MM, ONE (1) CORTEX SCREW 16MM THREE (3) CORTEX SCREWS 18MM, ONE (1) CORTEX SCREW 22MM, TWO (2) CORTEX SCREW 24MM, AND ONE (1) CORTEX SCREW 28MM WOULD NOT FIT THROUGH THE GUIDE BLOCK. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 16 DEVICES DUE TO THE SYSTEM LIMITATION, THIS INCIDENT WILL BE CAPTURED UNDER THIS (B)(4) (10 DEVICES) AND LINKED (B)(4) (6 DEVICES). THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW 18MM. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579527 ↗
• MalfunctionMay 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, POST-OPERATIVE, THE SCRUB NOTED FOLLOWING ON THE BACK TABLE: ONE (1) CORTEX SCREW 18MM BECAME INCARCERATED IN THE GUIDE BLOCK. ADDITIONALLY, THREE (3) CORTEX SCREWS 12MM, THREE (3) CORTEX SCREWS 14MM, ONE (1) CORTEX SCREW 16MM THREE (3) CORTEX SCREWS 18MM, ONE (1) CORTEX SCREW 22MM, TWO (2) CORTEX SCREW 24MM, AND ONE (1) CORTEX SCREW 28MM WOULD NOT FIT THROUGH THE GUIDE BLOCK. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 16 DEVICES DUE TO THE SYSTEM LIMITATION, THIS INCIDENT WILL BE CAPTURED UNDER THIS (B)(4) (10 DEVICES) AND LINKED (B)(4) (6 DEVICES). THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW 18MM. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579521 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION PROCEDURE ON (B)(6) 2015, THE PATIENT UNDERWENT AN OPEN TREATMENT OF LEFT ELBOW DISLOCATION WITH PRIMARY REPAIR OF ANTERIOR CAPSULAR AVULSION INJURY, A LEFT ELBOW RADIAL HEAD REPLACEMENT FOR FRACTURE AND A LEFT ELBOW PRIMARY REPAIR OF LATERAL ULNAR COLLATERAL LIGAMENT. ONCE THE INJURY WAS VISIBLE AFTER SUITABLE INCISION WAS MADE, THE SURGEON FOUND AN OBVIOUS CLEAR SOMATIC AVULSION OF THE LATERAL ULNAR COLLATERAL LIGAMENT OFF THE HUMORAL ATTACHMENT POINT, BUT THIS APPEARED TO BE INTACT DISTALLY ON THE ULNA. RADIAL HEAD FRACTURE SHOWED ALMOST FRAGMENTS. AFTER CLEANING THE WOUND SITE FOR BETTER VISUALIZATION OF THE OPERATING SITE, THE ARTICULAR SURFACE WAS LAGGED BACK TOGETHER WITH TWO (2) 2.0 MM LAG SCREWS, WITH HEADS COUNTERSUNK. THIS NOW STABILIZED THE ARTICULAR BLOCKS, WAS DIS-IMPACTED AND THEN A RADIAL HEAD LOCKING PLATE WAS APPLIED. ADDITIONAL LATERAL RADIOGRAPHS AFTER THE PROVISIONAL STABILIZATION SHOWED A NEAR-PERFECT REDUCTION; HOWEVER, THE ELBOW WAS WITH THE ELBOW BEING FULLY SUPINATED OR AT LEAST IN NEUTRAL POSITION. WITHOUT REALIZING THIS, THE SURGEON PROCEEDED TO STABILIZE IT FULLY WITH COMBINATION OF THREE (3) NONLOCKING SCREW

  Patient problems: No Code Available

  MAUDE report 7986658 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002271, K063049, K102694, K103243, K112583. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen
• Z-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor