MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 6MM X 25MM; SCREW, FIXATION, BONE

Catalog Number	72201769
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference: (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 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 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.
Event or Problem Description
It was reported that, less than two years after a knee ligament reconstruction surgery, which was performed on (b)(6) 2023, fragments of the biosure ha 6mm x 25mm screw that should've been resorbed long ago, were found in the patient during a revision surgery performed on (b)(6) 2025.It is unknown if the fragments were removed.Patient outcome is unknown.
Event or Problem Description
It was reported that, less than two years after a knee ligament reconstruction surgery, which was performed on (b)(6) 2023, fragments of the biosure ha 6mm x 25mm screw that should've been resorbed long ago, were found in the patient during a revision surgery performed on (b)(6) 2025, it was not necessary to implant another screw.All the fragments were removed, additionally, physical therapy and infiltration treatments were performed.Patient outcome was painful.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H2: additional information on a2, a3, a4, b5, b7 & h6 (health effect - impact code & medical device problem code).
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.Multiple small fragments were returned in a specimen bottle but does not appear to be the whole implant.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 no similar reported events.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 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.No further analysis was found the be required due to the condition of the device.Although a fracture was observed in evaluation, the ifu states "the material of the smith & nephew biosure ha interference screw is made from 75% poly-l-lactic acid (iplla) and 25% hydroxyapatite (ha).The polymer is substantially absorbed in three to five years".The root cause of the reported event could not be determined due to the limited clinical information provided.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: BIOSURE HA 6MM 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23457334
• Report Number: 1219602-2025-02713
• Device Sequence Number: 7885023
• Product Code: HWC
• UDI-Device Identifier: 03596010611659
• UDI-Public: 3596010611659
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

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: 72201769
• Device Lot Number: 50977311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/20/2025; 04/22/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/24/2025; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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; Other
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 60 KG