MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE SYNC 7-8MM TIBIAL FIXATION; SCREW, FIXATION, BONE

Model Number	72202745
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during acl reconstruction surgery, the biosure sync 7-8mm tibial fixation was fractured upon insertion, all the broken pieces were retrieved.The malfunction was solved with no significant delays or patient harm using a back up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that one of the four legs had broken off at the distal tip.The opposite leg was deformed.There was significant debris within the device.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: read these instructions completely prior to use.Breakage of the implant or loss of fixation may occur if the insertion site is not prepared properly.Prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.Use of screws longer than 25 mm may result in damage to the device.Failure to fully seat the fixation device may result in reduced fixation strength or breakage of the device during screw insertion.A clinical investigation found that it was reported that all the broken pieces were retrieved from the patient.Per the report, the malfunction was resolved with no significant delays or patient harm using a backup device.Therefore, no further clinical/medical assessment was warranted.The complaint was confirmed.Factors that could have contributed to the reported event include improper preparation of the insertion site, incomplete fixation, or use of incompatible accessories.No containment or corrective actions are recommended at this time.

• Brand Name: BIOSURE SYNC 7-8MM TIBIAL FIXATION
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11262879
• Report Number: 1219602-2021-00233
• Device Sequence Number: 19678554
• Product Code: HWC
• UDI-Device Identifier: 03596010648983
• UDI-Public: 03596010648983
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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 Expiration Date: 10/08/2024
• Device Model Number: 72202745
• Device Catalogue Number: 72202745
• Device Lot Number: 50830438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 105