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	No Information (3190)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2019, the surgeon implanted a 9x25 biosure regenesorb screw into the tibia as part of an acl reconstruction with no issues.On (b)(6) 2020, the patient went to clinic with swelling, redness and pain at the incision site.The patient was brought back into the or and upon the incision fragments of the screw were seen.Upon further dissection, more fragments of the screw were found and removed.With guidance of an arthroscope, the tibial tunnel was debrided of all remaining fragments and washed out.A 10x25 rci interference screw was then placed in the tibial tunnel in place of the fragmented biosure regenesorb interference screw.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 72204404 screw biosure regenesorb 9mm x 25mm, intended for use in treatment, has not returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customer¿s complaint cannot be confirmed.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was performed, no other complaints of this failure was found.

• Brand Name: SCREW BIOSURE REGENESORB 9MM 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: 10286460
• Report Number: 1219602-2020-01070
• Device Sequence Number: 16292801
• Product Code: MAI
• UDI-Device Identifier: 00885554036800
• UDI-Public: 00885554036800
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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: 08/24/2021
• Device Model Number: 72204404
• Device Catalogue Number: 72204404
• Device Lot Number: 50754799
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 09/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR