MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LID FOR OUTER CASES; TRAY, SURGICAL, INSTRUMENT

Model Number	71129402
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a field inspection the ipg mis dcf ap ct blk 3 was noted to be rusty and discolored, the extramedular alignment rod was broken, the gii quick connect handle dented and did not retract, the ipg ps high flex impctr hd 1-2 gii ps high flex impctr hd 3-8, gii tibial base impactor, gii narrow pcl retractor, 11mm gns ii tibial drill with burrs and gouges and outer housing cap with one component missing and broke.No case reported; therefore, there was no patient participation.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The handles are cracked on the device, rendering the device inoperable.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device shows signs of extensive use.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LID FOR OUTER CASES
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11646822
• Report Number: 1020279-2021-02827
• Device Sequence Number: 3072912
• Product Code: FSM
• UDI-Device Identifier: 03596010415103
• UDI-Public: 03596010415103
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71129402
• Device Catalogue Number: 71129402
• Device Lot Number: 485734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 04/11/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1