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

Model Number	72201887
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code (b)(6).
Event or Problem Description
It was reported that during a cross band the screwdriver was bent.It is unknown how was the procedure completed since it was reported that no back-up device was available.No patient injury, delay or 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
H3, h6: the reported biosure driver, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the device bent during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied to the device during use.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, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: BIOSURE DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9500911
• Report Number: 1219602-2019-01592
• Device Sequence Number: 11508572
• Product Code: HWR
• UDI-Device Identifier: 03596010615398
• UDI-Public: 03596010615398
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/20/2020

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: 72201887
• Device Catalogue Number: 72201887
• Device Lot Number: 50777707
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1