MAUDE Adverse Event Report: ARTHREX, INC. UCL INTERNAL BRACE IMPLANT SYSTEM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	UCL INTERNAL BRACE IMPLANT SYSTEM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
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 during a ucl reconstruction procedure, after the surgeon had finished the repair they started the internal brace portion of the surgery.Upon trying to implant the anchor within the ar-7715 ucl internal brace implant system, the anchor would not seat and continued to fall off the end of the inserter.No pieces of the anchor were left in the patient.The surgeon decided not to perform the internal brace portion of the case, and the surgery was completed.The complaint device was discarded and will not be returning for evaluation.

• Brand Name: UCL INTERNAL BRACE IMPLANT SYSTEM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9519500
• Report Number: 1220246-2019-01535
• Device Sequence Number: 491561
• Product Code: MAI
• UDI-Device Identifier: 00888867220980
• UDI-Public: 00888867220980
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/26/2019

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 Expiration Date: 04/30/2023
• Device Model Number: UCL INTERNAL BRACE IMPLANT SYSTEM
• Device Catalogue Number: AR-7715
• Device Lot Number: 10311710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/26/2019
• 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