MAUDE Adverse Event Report: ARTHREX, INC. INTERNALBRACE LIGAMENT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	INTERNALBRACE LIGAMENT
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/08/2019
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 requested/is expected but has 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 procedure while using the drill bit within the ar-1688-cp internal brace ligament implant system, shavings were being produced from the bit.Additional information received on 07/11/2019: the procedure taking place was an evans calcaneal osteotomy and fdl transfer with internal brace procedure.The facility reporter stated 2mm shavings were coming off of the drill bit.The surgeon attempted to remove all of the shavings, but they were very small so the surgeon irrigated the shavings out as best as possible.A second ar-1688cp was not opened, and the case was completed as normal.The procedure was open, and unplanned incision was not necessary.There was an arthrex sales representative present during the procedure.The device will be returning for evaluation.Additional information received on 07/17/2019: the bone was prepped by using a 2.7 cannulated drill.The rep reported that case proceeded as planned with no further issues.The surgeon did not express any concerns during or after the procedure.

• Brand Name: INTERNALBRACE LIGAMENT
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8845617
• Report Number: 1220246-2019-01217
• Device Sequence Number: 2494654
• Product Code: MAI
• UDI-Device Identifier: 00888867096080
• UDI-Public: 00888867096080
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

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: 03/31/2021
• Device Model Number: INTERNALBRACE LIGAMENT
• Device Catalogue Number: AR-1688-CP
• Device Lot Number: 10303071
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/31/2019
• 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