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

Catalog Number	72201887
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during set up, seven biosure drivers had metal fragments.It is unknown, if there was a back up device available.No surgical delay was reported and no patient involvement was reported.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However an image and video evaluation were performed and found there is metal fragments in all of them.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause of the reported event could not be determined since the device was not returned for evaluation.Factors that could have contributed to the reported event include improper storage conditions or improper routine maintenance of the device.No containment or corrective actions are recommended at this time.

• Brand Name: BIOSURE DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18732611
• Report Number: 1219602-2024-00308
• Device Sequence Number: 17715124
• Product Code: HWR
• UDI-Device Identifier: 03596010615398
• UDI-Public: 03596010615398
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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 Catalogue Number: 72201887
• Device Lot Number: 51163498
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown