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

Model Number	71355094
Medical Device Problem Code	Data Back-Up Problem (2902)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2020-00346
• Device Sequence Number: 547758
• Product Code: MEH
• UDI-Device Identifier: 00885556223093
• UDI-Public: 00885556223093
• Combination Product (Y/N): N
• PMA/510(K) Number: K113789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 71355094
• Device Catalogue Number: 71355094
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1