MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 7MM X 25MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204395
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the biosure screw snapped the distal 10mm off while being inserted into the anteromedial portal.The broken part was left embedded in the patient's tunnel and the dr fixed the graft using a zimmer biomet screw at the femoral cortex and a biosure regenesorb screw at the tibial end.An additional bone hole was drilled in the femoral cortex to implant the zimmer biomet anchor.There was a delay greater than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H3, 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.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.A clinical review states the material of the biosure screw is made of a biocomposite material which is intended for implantation to allow for bone ingrowth.The patient impact beyond the extended surgical time, possible corrosion, local irritation/discomfort, and/or migration of the retained fragment cannot be determined.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.
Additional Manufacturer Narrative
H11: h2: corrected data on: h6 (impact code).

• Brand Name: SCREW BIOSURE REGENESORB 7MM X 25MM
• 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: 18685205
• Report Number: 1219602-2024-00262
• Device Sequence Number: 6249516
• Product Code: MAI
• UDI-Device Identifier: 00885554036718
• UDI-Public: 00885554036718
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2026
• Device Catalogue Number: 72204395
• Device Lot Number: 51152195
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 03/20/2024; 09/23/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/28/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown