MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 5MM X 25MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204390
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the screw broke immediately when the screw was inserted to the driver.No patient injury or delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: one screw biosure regenesorb 5mm x 25mm, used in treatment, has returned for evaluation.The information provided states: ¿during a tibial fixation surgery, when screwing in the biosure regenesorb interference screw in the tibia, the doctor tried exert further force to screw in but then the whole screw was directly pushed inside the bone tunnel, the tunnel become widen and the screw was loosen¿.Visual assessment confirms complaint.Fragments of the screw were returned.There was a relationship between the reported even and the device.An exact root cause cannot be determined with confidence without the pertinent clinical details; however, factors that could have contributed to the reported event include: not preparing the insertion site as required by the instructions for use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.

• Brand Name: SCREW BIOSURE REGENESORB 5MM X 25MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10511739
• Report Number: 1219602-2020-01375
• Device Sequence Number: 3033721
• Product Code: MAI
• UDI-Device Identifier: 00885554036664
• UDI-Public: 00885554036664
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2022
• Device Model Number: 72204390
• Device Catalogue Number: 72204390
• Device Lot Number: 50789467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1