MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 8MM X 35MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204402
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an acl procedure, the biosure screw broke when it was being threaded into the patient.60% of the screw was removed with a grasper and the other distal 40% remained on the patient.The procedure was successfully completed without significant delay using a back-up device.No other complications were 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.A visual inspection performed on the product observed debris in the threads and the bottom half of the screw is broken off.Based on the condition of the product material found during visual inspection it was determined that additional material testing is not required.A review of the raw materials found that the storage requirements, material specifications, and material tests were appropriately documented.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.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device tip, attempted correction of a damaged device, or an inadvertent impact event.

• Brand Name: SCREW BIOSURE REGENESORB 8MM X 35MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10939683
• Report Number: 1219602-2020-01979
• Device Sequence Number: 2419057
• Product Code: MAI
• UDI-Device Identifier: 00885554036787
• UDI-Public: 00885554036787
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 06/03/2023
• Device Model Number: 72204402
• Device Catalogue Number: 72204402
• Device Lot Number: 50876995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 05/27/2021
• 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: Required Intervention