NA 402.876Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982206725), received between Sep 25, 2020 and Sep 23, 2026 — classified as 7 injuries, 2 malfunctions.

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

4 other recalls cover devices cleared under the same FDA submission (K050110, K063049, K112583, K962616); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874003 ↗
• MalfunctionAug 24, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50413878 ↗
• InjuryJul 17, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE FOR A DISTAL CLAVICLE FRACTURE. AFTER SURGERY, ON (B)(6) 2023, THE THREE SCREWS INSERTED AT THE DISTAL HOLES OF THE PLATE WERE FOUND TO BE BROKEN. REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023. BONE UNION WAS ACHIEVED, SO THE PLATE AND SCREWS WILL BE REMOVED. THIS REPORT INVOLVES ONE 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17332803 ↗
• InjuryJul 29, 2022Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: THE PATIENT WAS HOSPITALIZED ON (B)(6) 2022 FOR A FRACTURE OF THE DISTAL RADIUS REDUCED BY OSTEOSYNTHESIS. THE EXACT IMPLANT DATE IS UNKNOWN. THE PATIENT WAS RE-EXAMINED AFTER ONE MONTH AND PRESENTED WITH UNSCREWING OF THE IMPLANTS PLACED AS WELL AS BREAKAGE OF THE 4 DISTAL EPIPHYSEAL LOCKING SCREWS AT THE BODY-HEAD JUNCTION IN THE ABSENCE OF A FALL. ADDITIONALLY SECONDARY DISPLACEMENT OF THE FRACTURE SITE WITH EXTRA-ARTICULAR CALLUS OCCURRED. THE MATERIAL INITIALLY IMPLANTED WAS REMOVED DURING A SURGERY REVISION ON (B)(6) 2022 TO RECTIFY THE CALLUS AND NEW OSTEOSYNTHESIS BY PLATE. THIS IS REPORT 7 OF 9 FOR (B)(4). THIS REPORT IS FOR A CORTEX SCREW.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15134395 ↗
• InjuryJul 29, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: THE PATIENT WAS HOSPITALIZED ON (B)(6) 2022 FOR A FRACTURE OF THE DISTAL RADIUS REDUCED BY OSTEOSYNTHESIS. THE EXACT IMPLANT DATE IS UNKNOWN. THE PATIENT WAS RE-EXAMINED AFTER ONE MONTH AND PRESENTED WITH UNSCREWING OF THE IMPLANTS PLACED AS WELL AS BREAKAGE OF THE 4 DISTAL EPIPHYSEAL LOCKING SCREWS AT THE BODY-HEAD JUNCTION IN THE ABSENCE OF A FALL. ADDITIONALLY SECONDARY DISPLACEMENT OF THE FRACTURE SITE WITH EXTRA-ARTICULAR CALLUS OCCURRED. THE MATERIAL INITIALLY IMPLANTED WAS REMOVED DURING A SURGERY REVISION ON (B)(6) 2022 TO RECTIFY THE CALLUS AND NEW OSTEOSYNTHESIS BY PLATE. THIS IS REPORT 6 OF 9 FOR (B)(4). THIS REPORT IS FOR A CORTEX SCREW.

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

  MAUDE report 15134230 ↗
• InjuryJul 29, 2022Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: THE PATIENT WAS HOSPITALIZED ON (B)(6) 2022 FOR A FRACTURE OF THE DISTAL RADIUS REDUCED BY OSTEOSYNTHESIS. THE EXACT IMPLANT DATE IS UNKNOWN. THE PATIENT WAS RE-EXAMINED AFTER ONE MONTH AND PRESENTED WITH UNSCREWING OF THE IMPLANTS PLACED AS WELL AS BREAKAGE OF THE 4 DISTAL EPIPHYSEAL LOCKING SCREWS AT THE BODY-HEAD JUNCTION IN THE ABSENCE OF A FALL. ADDITIONALLY SECONDARY DISPLACEMENT OF THE FRACTURE SITE WITH EXTRA-ARTICULAR CALLUS OCCURRED. THE MATERIAL INITIALLY IMPLANTED WAS REMOVED DURING A SURGERY REVISION ON (B)(6) 2022 TO RECTIFY THE CALLUS AND NEW OSTEOSYNTHESIS BY PLATE. THIS IS REPORT 3 OF 9 FOR (B)(4). THIS REPORT IS FOR A CORTEX SCREW.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15133393 ↗
• InjuryJul 18, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE DISTAL CLAVICULAR OF RIGHT FRACTURE WITH THE PLATE AND SCREWS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2022, SEVERAL MALFUNCTIONS WERE OBSERVED IN OUTPATIENT FOLLOW-UP EXAMINATION AS FOLLOWS. THE RIGHT CLAVICLE HAS OBVIOUS TENTING. IT WAS CONFIRMED BY COMPUTED RADIOGRAPHY (CR) IMAGE THAT TWO SCREWS INSERTED INTO THE DISTAL BONE FRAGMENT WERE BROKEN. THOSE LOT OR SIZE COULD NOT BE IDENTIFIED. TWO OTHER SCREWS INSERTED INTO THE DISTAL BONE HAS BACKED OUT. THE PLATE HAS BEEN DISLODGED. THE PATIENT HAS NO SUBJECTIVE SYMPTOM. A REVISION SURGERY WILL OCCUR BUT IT IS NOT KNOWN IF IT HAS BEEN COMPLETED. THIS IS REPORT 9 OF 9 FOR (B)(4). THIS REPORT IS FOR A CORTEX SCREW.

  Patient problems: Failure of Implant

  MAUDE report 15044617 ↗
• InjurySep 25, 2020Off-Label Use; Off-Label Use

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN OPEN REDUCTION FIBULA AND TIBIA PROCEDURE, THE SURGEON IMPLANTED LATERAL DISTAL FIBULAR PLATES AND USED 2.7MM CORTICAL SCREWS IN THE BODY OF THE PLATE INSTEAD OF THE INDICATED 3.5MM SCREWS. AFTER A PREVIOUS PROCEDURE, THE SURGEON DIRECTED THE STAFF TO RETAIN 3.5MM SCREWS AND THEY WERE SENT TO BE STERILIZED. THE SURGEON BEGAN THE PATIENT'S PROCEDURE WITHOUT THE 3.5MM BEING AVAILABLE AS THEY WERE STILL BEING STERILIZED. AFTER BEING ADVISED THAT USING THE 2.7MM CORTICAL SCREWS COULD GENERATED COMPLICATIONS IN THE PATIENT, THE SURGEON PROCEEDED TO IMPLANT THE 2.7MM CORTICAL SCREWS. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 10588458 ↗
• InjurySep 25, 2020Off-Label Use; Off-Label Use

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN OPEN REDUCTION FIBULA AND TIBIA PROCEDURE, THE SURGEON IMPLANTED LATERAL DISTAL FIBULAR PLATES AND USED 2.7MM CORTICAL SCREWS IN THE BODY OF THE PLATE INSTEAD OF THE INDICATED 3.5MM SCREWS. AFTER A PREVIOUS PROCEDURE, THE SURGEON DIRECTED THE STAFF TO RETAIN 3.5MM SCREWS AND THEY WERE SENT TO BE STERILIZED. THE SURGEON BEGAN THE PATIENT'S PROCEDURE WITHOUT THE 3.5MM BEING AVAILABLE AS THEY WERE STILL BEING STERILIZED. AFTER BEING ADVISED THAT USING THE 2.7MM CORTICAL SCREWS COULD GENERATED COMPLICATIONS IN THE PATIENT, THE SURGEON PROCEEDED TO IMPLANT THE 2.7MM CORTICAL SCREWS. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 10587793 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050110, K063049, K112583, K962616. One submission often covers many models, so check the product and lot details in each record.

• 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