NA 202.878Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982145086), received between Dec 26, 2017 and Jul 10, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (K010321, K050110, K063049, K102694, K112583, K113364); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A PROCEDURE WITH THE CORTEX SCREW SLF-TPNG T8 SD REC 18. POSTOPERATIVELY, THE IMPLANTED ROD BROKE, AND PATIENT UNDERWENT ANOTHER PROCEDURE. PATIENT SUFFERED PAIN AS A RESULT OF THE EVENT. THE PATIENT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 22467531 ↗
• MalfunctionAug 19, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE DRILL BIT BROKE IN THE MIDDLE OF THE DRILL. SEVERAL SCREW HEADS APPEARED TO HAVE A BAD HEAD AND WERE NOT USED IN SURGERY. SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS NOTED AS OK. THIS IS REPORT 8 OF 11 FOR (B)(4). THIS REPORT IS FOR A CORTEX SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15261319 ↗
• InjuryJun 3, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE FOR THE CLAVICLE, THE CORTEX SCREW HEAD SHEARED OFF ON TIGHTENING IN THE MOST MEDIAL HOLE OF THE LATERAL CLAVICLE PLATE. THE SCREW HEAD WAS RETRIEVED AND THE SCREW SHAFT WAS RETAINED IN THE CLAVICLE. THE PLATE IS PLANNED TO BE REMOVED IN THREE TO NINE (3 ¿ 9) MONTHS AND THE SCREW SHAFT WILL BE REMOVED ALONG WITH IT. NO SURGICAL DELAY WAS ENCOUNTERED AS THE SCREW WAS LEFT AS IS AND THE OTHER HOLES OF THE PLATE WERE FILLED. THIS REPORT IS FOR A CORTEX SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14598000 ↗
• MalfunctionJul 3, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A SURGICAL PROCEDURE OF A BROKEN PALM FRACTURE TO FIX ULNA WITH A LOCKING COMPRESSION PLATE (LCP). UPON INSERTION OF THE FINAL CORTEX SCREW, THE HEAD OF THE SCREW CAME OFF. THE SURGEON DECIDED TO REMOVE THE ENTIRE CONSTRUCT TO REMOVE THE SCREW FRAGMENT AND UPON AN ATTEMPT TO REMOVE THE NEXT SCREW IN THE PLATE, THE SCREW CAME OFF. THE SURGEON REMOVED ALL THE SCREWS AND THE PLATE. A BROKEN SCREW REMOVAL SET WAS USED TO TAKE OUT THE SCREW FRAGMENT. THERE WAS A SURGICAL DELAY OF AN HOUR REPORTED TO AN ATTEMPT TO REMOVE THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: SCREWS (PART 202.873, LOT UNKNOWN, QUANTITY 3), 2.7MM CORTEX SCREW, SELF-TAPPING 16MM (PART 202.876, LOT UNKNOWN, QUANTITY 1), 2.7MM CORTEX SCREW, SELF-TAPPING 20MM (PART 202.880, LOT UNKNOWN, QUANTITY 1), 2.0MM LOCKING COMPRESSION PLATE 7 HOLES (PART 247.347, LOT NUMBER UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659002 ↗
• MalfunctionDec 26, 2017Break; Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ULNA PROCEDURE ON (B)(6) 2017, THE HEAD OF A 2.7MM 18MM CORTEX SCREW BROKE OFF INTO THE PATIENT AS THE SURGEON WAS SCREWING IT INTO A 2.7MM LOCKING COMPRESSION PLATE (LCP) PLATE. FRAGMENTS WERE GENERATED IN THE PATIENT AND PART OF THE SCREWS THREADING WAS REPORTED TO BE LEFT IN THE PATIENT¿S ARM. ALL OTHER FRAGMENTS WERE REPORTED AS EASILY REMOVED. DURING THE TIME OF THE BREAK, TWO (2) OTHER 2.7MM 18MM CORTEX SCREWS AND THE 2.7MM LCP PLATE WERE IMPLANTED IN THE PATIENT. THE PLATE AND 2 SCREWS REMAINED IN THE PATIENT AND THE SURGERY WAS COMPLETED USING ANOTHER 2.7MM 18MM CORTEX SCREW. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE PROCEDURE. THERE WAS A REPORTED 10-MINUTE SURGICAL DELAY DUE TO THE BREAK. CONCOMITANT DEVICE REPORTED: 2.7MM LCP PLATE 10 HOLES / 94MM (247.374, LOT NUMBER UNKNOWN, QUANTITY 1), SCREWDRIVER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7146262 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010321, K050110, K063049, K102694, K112583, K113364. 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-1274-2014 · Jan 7, 2014 · Terminated
  Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bon
• 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