MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 8MM X 30MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
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 (tibial fixation), the biosure regenesorb screw was broken into pieces.All pieces were retrieved from the patient using graspers.The procedure was successfully completed with a delay of less than 30 minutes using a smith and nephew back up device.The back up device was used in the original bone hole so no void was left in the patient.No further complications were reported.
Additional Manufacturer Narrative
H11: corrected information in h6 (health effect - impact code).
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).H6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: SCREW BIOSURE REGENESORB 8MM X 30MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 18619977
• Report Number: 1219602-2024-00195
• Device Sequence Number: 11372835
• Product Code: MAI
• UDI-Device Identifier: 00885554036770
• UDI-Public: 00885554036770
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K142948
• 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): 03/19/2024

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 Expiration Date: 10/18/2025
• Device Catalogue Number: 72204401
• Device Lot Number: 51075123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 03/17/2024; 03/17/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/18/2024; 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• 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