MAUDE Adverse Event Report: ARTHREX, INC. IB KIT, MINI, PEEK, CC FT, W/ JUMPSTART; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	IB KIT, MINI, PEEK, CC FT, W/ JUMPSTART
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
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 an ucl internal brace using ar-1787pj-cp, a mini ib 2.0 kit.The surgeon followed proper technique for anchor insertion and had no trouble with the first anchor but, the second anchor broke while he tried to insert it.The broken anchor was removed entirely and the case was completed using a 4.75 swivelock.

• Brand Name: IB KIT, MINI, PEEK, CC FT, W/ JUMPSTART
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11631663
• Report Number: 1220246-2021-02864
• Device Sequence Number: 3015633
• Product Code: MAI
• UDI-Device Identifier: 00888867295629
• UDI-Public: 00888867295629
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: IB KIT, MINI, PEEK, CC FT, W/ JUMPSTART
• Device Catalogue Number: AR-1787PJ-CP
• Device Lot Number: 12486023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1