MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 8MM X 25MM; SCREW, FIXATION, BONE

Catalog Number	72201776
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, when inserting the biosure helicoil screw into the tibial tunnel, it broke without exerting force, the device was removed in its entirety.The procedure was completed with a smith and nephew back up device with no surgical delay.The patient is stable, no further complications were reported.
Event or Problem Description
It was reported that during an arthroscopy, when inserting the biosure helicoil screw into the tibial tunnel, it broke without exerting force, the device was removed in its entirety.There wasn´t a void left in the patient the procedure was completed with a smith and nephew back up device using the original drilled bone hole with no surgical delay.The patient is stable, no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).B5 and h6 updated.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found the broken device outside of its package.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.A review of the material 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.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include off-axis insertion, or improper preparation of the insertion site.No containment or corrective actions are recommended at this time.

• Brand Name: BIOSURE HA 8MM 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: 19492254
• Report Number: 1219602-2024-01252
• Device Sequence Number: 15588021
• Product Code: HWC
• UDI-Device Identifier: 03596010611727
• UDI-Public: 03596010611727
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2024

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: 72201776
• Device Lot Number: 51194263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 06/21/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 06/25/2024; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2024
• 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