MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE REGEN SCREW 5 X 20MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204389
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a patellofemoral reconstruction, the biosure regenesorb screw broke in half.One half of the screw remained implanted in the patient, while the other half was removed using apprehension forceps.Due to this, a change in surgical technique was required, involving a lateral incision to knot the super sutures and a new line to complete the procedure.There is a risk of patellofemoral reconstruction failure, as concerns remain regarding the potential future yield of the remaining half-screw.A 5x20 ball tunnel and a 6x20 biosure screw were used for the insertion site preparation.The procedure was delayed by less than 30 minutes, a void was left and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

• Brand Name: BIOSURE REGEN SCREW 5 X 20MM
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 21757596
• Report Number: 1219602-2025-00763
• Device Sequence Number: 13302552
• Product Code: MAI
• UDI-Device Identifier: 00885554036572
• UDI-Public: 885554036572
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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: 72204389
• Device Lot Number: 51263810
• 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: 03/12/2025
• Initial Report FDA Received Date: 04/02/2025
• Date Device Manufactured: 10/18/2024
• 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 Age: 17 YR
• Patient Sex: Male
• Patient Weight: 75 KG