MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC SM FRAG INST & IMPLANT SET LID; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 71170660

Device Problems Break (1069); Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Event Description

It was reported that during set up for an internal fixation surgery, it was noticed that the lid was broken and peeling.No patient injury was reported.There was no significant delay and the procedure was finished using a smith & nephew back up.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection was performed and confirmed the tray lid is peeling and cracking.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed prior complaints for this failure mode.This failure mode has been previously identified.Since the manufacturing of the device, design changes have been implemented to eliminate/reduce the occurrence of this failure.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: PERI-LOC SM FRAG INST & IMPLANT SET LID
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11794827
• MDR Text Key: 249667810
• Report Number: 1020279-2021-03892
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00885556015933
• UDI-Public: 00885556015933
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71170660
• Device Catalogue Number: 71170660
• Device Lot Number: 11FAV0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1