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

Model Number	71631161
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a nail remotion, the multipurpose driver broke while trying to take out the nail screws.The procedure was finished using a smith and nephew back up device.Surgery was not delayed.The patient was not harmed beyond the described event.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, based on the limited information provided, the root cause of the reported breakage could not be determined.The material, 17-4 ph and 420 stainless steel, are manufactured and intended as an externally communicating device, not approved for implantation; therefore, long-term implantation data is not available.If retained the patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of possibly retained non-implantable foreign body fragments cannot be determined.No further medical assessment can be rendered at this time.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.A review of the risk management file revealed this failure mode was previously identified.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: MULTIPURPOSE DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10282977
• Report Number: 1020279-2020-03255
• Device Sequence Number: 667315
• Product Code: HWR
• UDI-Device Identifier: 03596010478450
• UDI-Public: 03596010478450
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 04/28/2021
• 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