MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PATELLA RESECTION GUIDE; PRSTHSIS,KNEE,PATLLO/FEMROTIBL,SMICONSTRIND,UNCMNTD,POROUSPOLYMR/MTAL

Model Number 71440391

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2020

Event Type  malfunction  

Event Description

It was reported that, during set up and inspection, the screws came out of the patella resection guide.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.The visual inspection of the returned device confirms one of the screws is missing from the device.The missing screw was returned with the device.This device exhibits signs of significant wear/usage.This device was manufactured in 2019.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.We consider this investigation closed.

• Brand Name: PATELLA RESECTION GUIDE
• Type of Device: PRSTHSIS,KNEE,PATLLO/FEMROTIBL,SMICONSTRIND,UNCMNTD,POROUSPOLYMR/MTAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10460049
• MDR Text Key: 204556679
• Report Number: 1020279-2020-04244
• 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
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/26/2020
• Device Model Number: 71440391
• Device Catalogue Number: 71440391
• Device Lot Number: 19LSP0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Date Manufacturer Received: 05/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1