MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 7MM X 25MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204395
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an arthroscopic procedure for an acl repair, the patient had a right knee scope postoperative that confirmed a graft failure.The event was treated with physical and medication therapy.The outcome of the patient was unresolved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6 h10: the reported 7x25mm 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 patient had a right knee scope postoperative that confirmed a graft failure.An exact root cause cannot be determined with confidence with the information that was provided.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, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SCREW BIOSURE REGENESORB 7MM 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: 10091592
• Report Number: 1219602-2020-00820
• Device Sequence Number: 14314751
• Product Code: MAI
• UDI-Device Identifier: 00885554036718
• UDI-Public: 885554036718
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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 Catalogue Number: 72204395
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 07/27/2020
• 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
• Patient Age: 43 YR