MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 9MM X 30MM; SCREW, FIXATION, BONE

Catalog Number	72201782
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.The distal tip of the anchor is fractured.Bio debris is present.These findings are related to the reported event.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 review of the product specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.Based on the condition of the product material found during visual inspection, it was determined the device damage was caused by the application of improper/excessive force.Additional material testing is not required.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the fractured implant include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (excessive force, off-axis insertion, or improper preparation of the insertion site).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.
Event or Problem Description
It was reported that during an acl procedure, the doctor found that the screw of the biosure was loose when he tried to implant it, and the screw slipped, it could not be twisted into the target position.Furthermore, the implant broke while the device was being used inside the patient; the broken component was removed from the patient using suction.The procedure was successfully completed using a smith and nephew back up device in the originally drilled bone hole, no void was left in the patient.There was a surgical delay of less than 30 minutes, and no further complications were reported.

• Brand Name: BIOSURE HA 9MM 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22915844
• Report Number: 1219602-2025-02143
• Device Sequence Number: 18668711
• Product Code: HWC
• UDI-Device Identifier: 03596010611789
• UDI-Public: 3596010611789
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: 72201782
• Device Lot Number: 51175131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2023
• 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