MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 8 MM X 30MM; SCREW, FIXATION, BONE

Catalog Number	72201778
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl reconstruction surgery, the biosure ha anchor was unstable after implantation and was removed from the patient.The procedure was completed using a s+n back up device into an additional bone hole.There was a surgical delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed that it is not in its original packaging.The device has deformation along the length and has a large amount of biological debris on the exterior and in the channel.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no 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.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences.Factors, that can contribute to the complaint event, include an application of unintended inappropriate or excessive force to the device.Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.

• Brand Name: BIOSURE HA 8 MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 20015997
• Report Number: 1219602-2024-01775
• Device Sequence Number: 8600791
• Product Code: HWC
• UDI-Device Identifier: 03596010611741
• UDI-Public: 3596010611741
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 72201778
• Device Lot Number: 51012450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown