MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T6 DRIVER SHAFT W/AO QC; SCREWDRIVER

Model Number	71174921
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon inspection the box label code was mistaken.The instruments inside the box were different, the actual products inside were 71174821, with batch lot 18mup0006.There was no case involved.The event was an out of the box failure.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states the failure was found during inspection and there are no previous serious events for this malfunction, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: T6 DRIVER SHAFT W/AO QC
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10171821
• Report Number: 1020279-2020-02562
• Device Sequence Number: 11342371
• Product Code: HXX
• UDI-Device Identifier: 00885556387344
• UDI-Public: 00885556387344
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2020

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: 71174921
• Device Catalogue Number: 71174921
• Device Lot Number: 18MUP0006A
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 06/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1