MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REAMER QUICK CONNECT; PRSTHSIS, HIP, SM-CONSTRAINED, UNCMNTD, MTL/PLYMR, NON-POROUS

Model Number 71355094

Device Problem Data Back-Up Problem (2902)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  malfunction  

Event Description

It was reported that when setting up for the case when connecting the reamer quick-connect handle to the distal reamer it was difficult pulling back the shaft of the quick connect handle.Nurse was directed to try the second handle and found the same issue.He was then told to gently tap the handle on the edge of the tray to help loosen the shaft and large shards of dried blood fell from both handles into the tray of reamers.That tray was deemed unsterile and as there are no alternatives to the reamer quick connect handles the surgeon had no other option but to use a competitor system.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 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.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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: REAMER QUICK CONNECT
• Type of Device: PRSTHSIS, HIP, SM-CONSTRAINED, UNCMNTD, MTL/PLYMR, NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9610398
• MDR Text Key: 177239073
• Report Number: 1020279-2020-00346
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 00885556223093
• UDI-Public: 00885556223093
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71355094
• Device Catalogue Number: 71355094
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1