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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the biosure 7mm was found to be broken before the case.Unknown if there was backup available or if the procedure was delayed.No other complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
"a 72203253 flexible tap biosure 7mm used in treatment was returned for evaluation.This is a one year old reusable instrument.Visual assessment confirms complaint.The instrument has been broken where the solid shaft transitions to the puzzle piece flex section.An exact root cause cannot be determined, however factor that may affect functionality include, excessive force and proper cleaning.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was performed, no other complaints of this failure was found.".

• 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: 10165659
• Report Number: 1219602-2020-00933
• Device Sequence Number: 3573281
• 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): 07/09/2020

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: 50791209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1