MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE SYNC,9-10MM ,TIBIAL FIXATION; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202746
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the biosure sync 9-10mm tibial fixation was implanted, when twisting the screw, biosure sync broke in the bone tunnel, then took out the screw and broken biosure sync in turn, implanted the screw again without a new biosure sync to complete the surgery.No patient injury was reported.
Additional Manufacturer Narrative
Visual assessment of the device shows two of the four fins have broken off.The break area shows signs of plastic deformation.The fins appear to have been stressed to failure.Dimensional inspection confirmed the device met print specification.This investigation could not identify any evidence of product contribution to the reported complaint.Device evaluated by the manufacturer.Evaluation codes updated.

• Brand Name: BIOSURE SYNC,9-10MM ,TIBIAL FIXATION
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7057830
• Report Number: 1219602-2017-01470
• Device Sequence Number: 1851927
• Product Code: MBI
• UDI-Device Identifier: 03596010648990
• UDI-Public: (01)03596010648990(17)220103(10)50639236
• Combination Product (Y/N): N
• PMA/510(K) Number: K093943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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 Expiration Date: 01/03/2022
• Device Model Number: 72202746
• Device Catalogue Number: 72202746
• Device Lot Number: 50639236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 11/24/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 80