MAUDE Adverse Event Report: ARTHREX, INC. INTBRACE LGMNT REPR AUGMNT KIT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	INTBRACE LGMNT REPR AUGMNT KIT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that when the surgeon inserted the ar-1678-cp, the 3.5mm swivel would not insert.Upon confirmation, the outer cylinder was torn even though the screw was not broken.The case was completed by using a new ar-1678-cp.No patient harm.

• Brand Name: INTBRACE LGMNT REPR AUGMNT KIT
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12362119
• Report Number: 1220246-2021-03545
• Device Sequence Number: 3536650
• Product Code: MAI
• UDI-Device Identifier: 00888867020887
• UDI-Public: 00888867020887
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101823
• 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): 08/24/2021

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: 05/31/2023
• Device Model Number: INTBRACE LGMNT REPR AUGMNT KIT
• Device Catalogue Number: AR-1678-CP
• Device Lot Number: 13567613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1