MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MULTIPURPOSE DRIVER; DRIVER, PROSTHESIS

Model Number	71631161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during surgery that the tip of a multipurpose driver broke during recon screw removal.Procedure was completed with a competitor device, a delay of 30 or less minutes was reported.No patient harm reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The visual inspection confirms a piece of the end of the driver broke off.The broken piece was not returned with the device.The long multi-purpose driver shaft and ring were not returned as well.The device is worn and shows significant signs of use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.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 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: MULTIPURPOSE DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12471634
• Report Number: 1020279-2021-06843
• Device Sequence Number: 19777985
• Product Code: HWR
• UDI-Device Identifier: 03596010478450
• UDI-Public: 03596010478450
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71631161
• Device Catalogue Number: 71631161
• Device Lot Number: 10MNM0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention