MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 9MM X 30MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204405
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a knee surgery the biosure regenesorb 9 x 30mm was difficult to insert, the tip flatten and creaked when it was removed.The device break inside the patient and it was retrieved using tweezers.The procedure was successfully completed without a 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 9x30mm biosure regenesorb screw, used in treatment, will not be 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 was difficult to insert, the tip flattened and cracked when it was removed.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: 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 device 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.

• Brand Name: SCREW BIOSURE REGENESORB 9MM X 30MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10136351
• Report Number: 1219602-2020-00872
• Device Sequence Number: 3791777
• Product Code: MAI
• UDI-Device Identifier: 00885554036817
• UDI-Public: 885554036817
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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: 01/03/2023
• Device Catalogue Number: 72204405
• Device Lot Number: 50849262
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/07/2020
• 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: Other; Required Intervention