MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 9MM X 25MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204404
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an anterior cruciate ligament graft, the interference screw fractured during placement in the femoral tunnel.Changing the screw was impossible.It is unknown if there were delays or a back up available, as well as how was the surgery completed.Patient outcome is unknown.
Additional Manufacturer Narrative
The reported 9x25mm biosure regenesorb screw, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the screw broke during insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not preparing the insertion site with the proper prep device.Excessive force placed on the screw during insertion.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.Further investigation is not warranted at this time.This complaint reports that the biosure screw fractured during insertion.No information has been provided to clarify whether any fragments of the biosure screw were retained in the patient, if a delay occurred, or how the procedure was completed.No patient injuries reported.Without the requested clinical information the root cause of the reported screw fracture cannot be determine.The material of the biosure screw is made of a biocomposite material which is intended for implantation to allow for bone ingrowth.However, if retained, it is unknown if the biosure screw will migrate and there is potential risk for tissue inflammation and/or pain.Should any additional clinical information be provided this complaint will be re-evaluated.No further clinical assessment is warranted at this time.

• Brand Name: SCREW BIOSURE REGENESORB 9MM X 25MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 10022847
• Report Number: 1219602-2020-00710
• Device Sequence Number: 2986557
• Product Code: MAI
• UDI-Device Identifier: 00885554036800
• UDI-Public: 00885554036800
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/16/2020

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: 03/29/2022
• Device Model Number: 72204404
• Device Catalogue Number: 72204404
• Device Lot Number: 50796783
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 06/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1