Locking Plates PS8Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842188100840), received between Dec 2, 2025 and May 4, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K060041); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Break

  SALES REP REPORTED ON 09APR2026 THAT A PS8 BROKE AND REQUIRED REMOVAL. THE REP STATED THE REMOVAL CASE OCCURRED ON (B)(6) 2026, THE PATIENT DID NOT FALL, THE PATIENT IS LARGER WEIGHING OVER 300 POUNDS, SEEMS TO BE YOUNG BUT NO OTHER MEDICAL ISSUES ARE KNOWN. IT IS UNKNOWN IF THE PATIENT WAS FOLLOWING ALL POST-OP INSTRUCTIONS. ADDITIONALLY, THE SURGEON OPTED TO REPLACE THE TRIMED PLATE WITH A LARGER SYNTHES PLATE. THE REP ATTEMPTED TO RETRIEVE THE BROKEN PLATE HOWEVER THE FACILITY HAD ALREADY DISCARDED IT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 25074698 ↗
• InjuryDec 2, 2025Break; Fracture; Break; Fracture

  DISTRIBUTOR REPORTED ON (B)(6) 2025 THAT THERE WAS A BROKEN PS8 FOUND IN AN X-RAY ON (B)(6) 2025 AFTER THE PATIENT ARRIVED AT A FOLLOW-UP APPOINTMENT REPORTING PAIN. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2025 AND IT WAS STATED THAT ACCORDING TO THE ATTENDING PHYSICIAN, THE PATIENT WAS NOT VERY COOPERATIVE WITH THE POST-OPERATIVE PROTOCOL. THEREFORE, AFTER THE SURGERY BUT PRIOR TO THE FOLLOW UP X-RAY, THE DOCTOR DECIDED TO APPLY AN ACRYLIC PLASTER CAST TO IMMOBILIZE THE WRIST AND FOREARM. THE BROKEN PLATE WAS DISCOVERED AFTER THE PLASTER CAST WAS APPLIED SO THE DOCTOR REQUESTED SURGICAL INTERVENTION ON (B)(6) 2025 FOR THE REMOVAL OF MATERIAL AND THAT THE PATIENT REQUESTED THE CHANGE OF MATERIAL TYPE FROM STEEL TO TITANIUM. IT WAS REPORTED TO TRIMED ON (B)(6) 2025, THAT THERE IS NO EVIDENCE SUGGESTING A PRODUCT DEFECT. PRELIMINARY INFORMATION INDICATES THAT THE PATIENT SUFFERED A FALL POSTOPERATIVELY, WHICH MAY EXPLAIN THE EVENT. HOWEVER, THE CASE IS BEING FOLLOWED LOCALLY FOR A COMPLETE EVALUATION. THERE WAS ABOUT A 0-5 MINUTE DELAY IN SURGERY DUE TO THE SURGEONS SCHEDULE BUT THE REMOVAL WAS SUCCESSFUL. DUE TO PATIENT DISCOMFORT AND NON-UNION THERE IS A REPORTED ADVERSE EVENT.

  Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23699869 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060041. One submission often covers many models, so check the product and lot details in each record.

• Z-1214-2019 · Aug 24, 2018 · Terminated
  TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle
• Z-0366-2020 · Aug 15, 2018 · Terminated
  TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset
• Z-2849-2016 · Aug 29, 2016 · Terminated
  TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of sur