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

Model Number 72202745

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2019

Event Type  malfunction  

Event Description

It was reported that during an acl reconstruction surgery the device was found fractured and it was removed with tweezers.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported 7-8 mm biosure sync tibial fixation device, used in treatment, has been returned for evaluation.Visual assessment of the device shows one of the four fins has broken off and was not returned for examination.The remaining fins are bent and twisted and are missing small pieces.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force/torque applied to the device during use.Improper site preparation.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BIOSURE SYNC 7-8MM TIBIAL FIXATION
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9572199
• MDR Text Key: 174513738
• Report Number: 1219602-2020-00060
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010648983
• UDI-Public: 03596010648983
• Combination Product (y/n): N
• PMA/PMN Number: K093943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2023
• Device Model Number: 72202745
• Device Catalogue Number: 72202745
• Device Lot Number: 50715881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR