MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 8MM X 20MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204398
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgery while the femoral tunnel was drilled, the biosure regenesorb wire was inserted and 8 mm tap was utilized.During the insertion of the screw, it broke into multiple pieces.All the pieces were removed form the patient.The procedure was completed without a significant delay using a 9mm cannu flex silk screw as a backup 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 shattered screw pieces with debris.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 20MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10865722
• Report Number: 1219602-2020-01866
• Device Sequence Number: 19532845
• Product Code: MAI
• UDI-Device Identifier: 00885554036749
• UDI-Public: 00885554036749
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 02/25/2022
• Device Model Number: 72204398
• Device Catalogue Number: 72204398
• Device Lot Number: 50789464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 05/28/2021
• 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