MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 9MM X 25MM; SCREW, FIXATION, BONE

Catalog Number	72201781
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an acl reconstruction surgery, the biosure screw broke.The procedure was completed placing a s+n back up device into the originally bone hole.Device.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection revealed that it is not in its original packaging.The distal end of the device is fractured in a spiral nearly to the proximal end with some material missing, there is biological debris on the returned device.Based on the condition of the product material found during visual inspection, additional material testing is not required.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 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 review of the anchor material specification, 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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H10: upon review of the description of the occurrence, it was determined that this event did not lead to death or serious deterioration in the state of health of a patient, user or other person.According to information received, it was confirmed that the anchor breakage did not took place internal to patient, but external.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.H11: corrected information in h10.

• Brand Name: BIOSURE HA 9MM X 25MM
• 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: 19418185
• Report Number: 1219602-2024-01186
• Device Sequence Number: 8540235
• Product Code: HWC
• UDI-Device Identifier: 03596010611772
• UDI-Public: 03596010611772
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2024

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: 72201781
• Device Lot Number: 51042385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 06/27/2024; 07/04/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 07/02/2024; 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• 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