MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE SYNC 7-8MM TIBIAL FIXATION; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202745
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a cl procedure, a biosure sync 7-8mm tibial fixation was fractured.The insertion site was cleared of all debris prior to insertion and all the pieces were removed from the patient with forceps.The procedure was resumed, after a non-significant delay, using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6 the reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.One fin was fractured from the device and was not returned.A second fin was returned bent and fractured from the device.The third fin is bent and the fourth has no visible defect.Based on the condition of the product material found during visual inspection, additional material testing is not required.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.A review of the product specifications found that tensile strength requirements are specified.A material certificate of analysis (coa) is required for raw material.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the reported event include an inadvertent impact event that may have occurred during device transportation, rough shipping and handling, or at the customer site, as well as the application of an unintended, inappropriate, or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: BIOSURE SYNC 7-8MM TIBIAL FIXATION
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, 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: 24617120
• Report Number: 1219602-2026-00796
• Device Sequence Number: 18551750
• Product Code: MBI
• UDI-Device Identifier: 03596010648983
• UDI-Public: 3596010648983
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093943
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 72202745
• Device Lot Number: 51185576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 12/08/2023
• 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
• Patient Age: 46 YR
• Patient Sex: Male