MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T7 DRIVER SHAFT W/AO QC; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	71174927
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the end of the driver was found to be rounding off.It happened outside the patient.No patient affectation.No delay reported.The procedure could be finished using an s&n backup device.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation, the reported event could not be confirmed.Therefore, product analysis could not be performed at this time.A review of the manufacturing record did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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.

• Brand Name: T7 DRIVER SHAFT W/AO QC
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10099246
• Report Number: 1020279-2020-01896
• Device Sequence Number: 3406084
• Product Code: MDM
• UDI-Device Identifier: 00885556387641
• UDI-Public: 885556387641
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: No Information
• Device Catalogue Number: 71174927
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1