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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Subcutaneous Nodule (4548)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, a patient in which a biosure regenesorb interference screw was implanted, developed pain after a certain period of time, and a portion of the screw became palpable beneath the skin.Over time, the screw appeared to gradually back out from its original position.On (b)(6) 2026, the patient underwent an operation to remove the screw crumbs.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: case-(b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known risks with the device itself or with its use 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 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.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H2: additional information: h6: health effect - clinical code.H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no 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 was 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 clinical review was performed and found one intraoperative photo and one undated x-ray image was provided for review which supports removal of the screw and the x-ray image confirms the screw is protruding from the bone surface.This does not confirm migration or how close it is to the skin surface.Based on the information provided the clinical root cause of the reported pain was likely due to the reported biosure sure backing out.The clinical root cause for the reported screw ¿backing out¿ and fragmentation could not be determined.We are unable to rule out patient bone quality, trauma, and activity level as likely contributory factors.We are also unable to confirm adequate initial fixation.The device ifu does warn that ¿pathological changes in soft tissue may impair the ability to securely affix the soft tissue to bone." based on this investigation, the need for corrective action is not indicated.

• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24490394
• Report Number: 1219602-2026-00679
• Device Sequence Number: 5092424
• Product Code: MAI
• UDI-Device Identifier: 00885554036770
• UDI-Public: 885554036770
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 06/17/2026

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 Catalogue Number: 72204401
• Device Lot Number: UNKNOWN
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 06/13/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 06/17/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 57 KG