MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE TAP BIOSURE 7MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72203253
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the flexible tap was found broken before the case.There was a back-up device available.No delay occurred.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 7mm flexible biosure tap, used in treatment, will not be returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, tap was found broken before the case.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive forces applied during previous use.Improper cleaning or storage.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: FLEXIBLE TAP BIOSURE 7MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10212723
• Report Number: 1219602-2020-00966
• Device Sequence Number: 16782180
• Product Code: LXH
• UDI-Device Identifier: 00885554027198
• UDI-Public: 00885554027198
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K080358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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: 72203253
• Device Catalogue Number: 72203253
• Device Lot Number: 50751537
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1