MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 6MM X 20MM; SCREW, FIXATION, BONE

Catalog Number	72201768
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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 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.
Event or Problem Description
It was reported that during a ligamentoplasty, when attempted to insert and screw the biosure screw into the patient's knee.The screw broke inside the patient.All the broken parts were removed from the patient.Upon inspection, it was found that this screw did not match the screws normally used (different composition).The surgery was completed using an equivalent sn back-up device.It is unknown if there was surgical delay.No further complications were reported.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.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 packaging process summary found that before placing anything inside the carton, perform a 100% in-process inspection on all packaged components.Ensure the pouch label, patient label, ifu and carton label have the correct part number and lot number per the work order.Although a manufacturing record review could not be conducted due to insufficient product identification information, the root cause of the reported event has been traced to a manufacturing issue.Based on this investigation a corrective actions and a field actions were initiated to mitigate this issue.As corrective actions, all procedures related to the packaging process were reviewed and updated to performed a 100% inspection criterial of the packaging and work order label.Therefore, further corrective actions are not indicated.

• Brand Name: BIOSURE HA 6MM X 20MM
• 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: 23556652
• Report Number: 1219602-2025-02856
• Device Sequence Number: 15983313
• Product Code: HWC
• UDI-Device Identifier: 03596010611642
• UDI-Public: 3596010611642
• 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: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: 72201768
• Device Lot Number: UNKNOWN
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 02/04/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0957-2026
• Patient Sequence Number: 1
• Patient Sex: Unknown