MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE SYNC 5-6MM TIBIAL FIXATION; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202744
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an cl reconstruction surgery, when the package was opened, the wing of the biosure was broken.The procedure was completed with a backup device and no significant delay or further complications reported.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.An analysis of the customer provided images revealed that one leg had broken off of the device.A visual inspection concluded that a leg of the device had broken off at the distal end.The device did not have any debris, and did not appear to have been removed from the packaging.The box did not have significant damage.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.The complaint was confirmed and the root cause was associated with transport or storage.Factors that could have contributed to the reported event include rough shipping and handling or an impact event during transportation or at the customer site.

• Brand Name: BIOSURE SYNC 5-6MM TIBIAL FIXATION
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11313291
• Report Number: 1219602-2021-00298
• Device Sequence Number: 1115343
• Product Code: MBI
• UDI-Device Identifier: 03596010648976
• UDI-Public: 03596010648976
• 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: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: 07/10/2023
• Device Model Number: 72202744
• Device Catalogue Number: 72202744
• Device Lot Number: 50746171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 72