MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII P/S CONS HOUSING REAM DOME; PRSTHSS, KN, PTLL/FMRTBL, SM-CNSTRND, NCMNTD, PRS, CTD, PLYMR/MTL/PLYMR

Catalog Number 71440145

Device Problem Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2020

Event Type  malfunction  

Event Description

It was reported that the instrument needs replacing due to wear and tear of use.No case involved.

Manufacturer Narrative

The device, intended use in treatment, was returned for evaluation.A visual inspection confirmed the gii p/s cons housing ream dome shows nicks and scratches.The device shows significant signs of wear/usage.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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: GII P/S CONS HOUSING REAM DOME
• Type of Device: PRSTHSS, KN, PTLL/FMRTBL, SM-CNSTRND, NCMNTD, PRS, CTD, PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10126555
• MDR Text Key: 194302234
• Report Number: 1020279-2020-02012
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010471338
• UDI-Public: 3596010471338
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71440145
• Date Manufacturer Received: 09/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1