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 Consequences Or Impact To Patient (2199)
Date of Event	09/03/2019
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 that using internal brace for lateral ankle repair.The 1.35mm k-wire was inserted into the talus, and the 2.7mm cannulated drill was used over the k-wire.As the surgeon started drilling into the bone, the drill bit fractured into multiple pieces.Fragments had to retrieved from the patient.Surgery continued with the other drill bits and swivelock anchors, and the end result was fine, with no harm to the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device solid 2.7mm drill in the internal brace.It was not necessary to switch the surgical technique or do a second surgery.On 14-feb-2020 (b)(6): the end user reported this incident to the (b)(6) authority - (b)(6).The end user stated that while drilling over a previously inserted k-wire, the cannulated drill shattered in the patients bone bending the k-wire and leaving shrapnel in the bone.The k-wire was removed and the surgeon took an x-ray of the patients ankle.It was found that most of the metal fragments were removed but some were too deep to remove without causing further trauma.

• 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: 9756832
• Report Number: 1220246-2020-01740
• Device Sequence Number: 2787591
• 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: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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: 05/31/2021
• Device Model Number: INTBRACE LGMNT REPR AUGMNT KIT
• Device Catalogue Number: AR-1678-CP
• Device Lot Number: 10319171
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other