SideWinder Fracture Plates SWOR-7MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842188101458), received between Jan 21, 2022 and Jan 21, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2022Break; Break

  A TRIMED DISTRIBUTOR FROM (B)(6), NOTIFIED TRIMED ON 05 DEC 2021 THAT A SWOR-7M HAD BROKEN AND NEEDED TO BE REMOVED FROM THE PATIENT. THE DATE BELIEVED TO BE THE DATE OF REMOVAL WAS (B)(6) 2021. IT IS CURRENTLY BELIEVED THAT THE BREAK IN THE PLATE WAS CAUSED BY A NONUNION, HOWEVER ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH NO RESPONSE YET. THIS DEVICE WAS IMPLANTED FOR APPROXIMATELY 3 MONTHS BEFORE THE BREAK WAS DETECTED IN AN X-RAY WHICH PROMPTED THE REMOVAL OF THE DEVICE. IT IS CURRENTLY BELIEVED THAT THE PATIENT HAS SINCE STARTED HEALING WELL, HOWEVER ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH NO RESPONSE YET. ADDITIONAL INFORMATION WAS REQUESTED ON THE FOLLOWING DATES, 06 DEC 2021, 09 DEC 2021, 14 DEC 2021, 16 DEC 2021, 28 DEC 2021 AND 03 JAN 2022, WITH NO ADDITIONAL INFORMATION PROVIDED AS OF 04 JAN 2022.

  Patient problems: Fall; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13322318 ↗

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 Ank
• 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