MAUDE Adverse Event Report: ARTHREX, INC. IMP SYS, ARTHREX BROSTROM REPAIR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMP SYS, ARTHREX BROSTROM REPAIR
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a dex procedure, the surgeon used ar-8936bc-cp, and one of the 3.0 anchors came completely out of the brocaded hole and all the repair was lost.A different device was used as the surgeon had to switch to another technique to complete the case.Additional information provide 12/9/2020: the surgeon had to revert to an open procedure in order to complete the case.

• Brand Name: IMP SYS, ARTHREX BROSTROM REPAIR
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11170504
• Report Number: 1220246-2021-02472
• Device Sequence Number: 2994366
• Product Code: MAI
• UDI-Device Identifier: 00888867051263
• UDI-Public: 00888867051263
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/14/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: IMP SYS, ARTHREX BROSTROM REPAIR
• Device Catalogue Number: AR-8936BC-CP
• Device Lot Number: 11994829
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 01/14/2021
• 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