MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PATELLA RESECTION GUIDE; PRSTHS,KN,PT/FMTB,SM-CNSTRND,UNCMNTD,PRS,CTD,PL/MT

Model Number 71440391

Device Problems Decoupling (1145); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2020

Event Type  malfunction  

Event Description

It was reported during efip inspection, it was found that the resection guide is not intact.After investigation, it was confirmed that the device has 2 retaining screws and 1 threaded sleeve missing from the device, rendering the device inoperable.No patient involved in the case.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection was performed and confirmed the device has 2 retaining screws and 1 threaded sleeve missing, 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.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.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.Based on this investigation, the need for corrective action is not indicated.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: PATELLA RESECTION GUIDE
• Type of Device: PRSTHS,KN,PT/FMTB,SM-CNSTRND,UNCMNTD,PRS,CTD,PL/MT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10784373
• MDR Text Key: 214525692
• Report Number: 1020279-2020-06110
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010453945
• UDI-Public: 03596010453945
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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: No Information
• Device Model Number: 71440391
• Device Catalogue Number: 71440391
• Device Lot Number: 18HSP0006
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1