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	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2020
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 an anterior talofibular ligament repair and augmentation a 3.5mm swivelock anchor was inserted.While the anchor was pushed into the bone the inserter became bent after force was applied.Once the handle was engaged the anchor screwed in but the top portion of the anchor snapped off on the handle.The surgeon decided that the construct is strong and stable enough and finished the procedure successfully.
Additional Manufacturer Narrative
Complaint confirmed.One 3.5 mm swivelock from an ar-1678-cp pack was received for investigation.Visual inspection identified that the distal end of the swivelock drive shaft had been bent, and approximately 6.21 mm of the associated biocomposite anchor remained along the shaft.No other fragments of the broken biocomposite anchor were returned.Due to the damaged condition of the biocomposite anchor fragment that was received, dimensions could not be accurately ascertained.Material analysis concluded that the swivelock met all as-received specifications.As such, this event is most likely the result of user applied mechanical forces via prying/leveraging during insertion, and/or improper bone preparation.

• 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: 10240599
• Report Number: 1220246-2020-01943
• Device Sequence Number: 16743824
• Product Code: MAI
• UDI-Device Identifier: 00888867020887
• UDI-Public: 00888867020887
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: INTBRACE LGMNT REPR AUGMNT KIT
• Device Catalogue Number: AR-1678-CP
• Device Lot Number: 10448965
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 09/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other