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

Model Number	INTERNALBRACE LIGAMENT
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)
Date of Event	06/13/2018
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.It was reported the device was discarded at time of procedure.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the patient underwent an internal brace and brostrom repair procedure on (b)(6) 2017 where an ar-1688-cp, lot: 10154871 and two ar-1915ft¿s, lot: 10160922 were implanted.The patient healed properly after the procedure, however, the incision took a long time.A few months later, the patient began to experience pain and swelling at the incision site.Seven months post-op, on (b)(6) 2018, the patient underwent a revision surgery where the internal brace and both corkscrew anchors were removed due the patient being allergic to nickel.Additional information obtained: both procedures were performed at the same surgery center by the same surgeon.No implants replaced the internal brace and corkscrews in the lateral ankle.

• 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: 7683215
• Report Number: 1220246-2018-00536
• Device Sequence Number: 18994079
• Product Code: MAI
• UDI-Device Identifier: 00888867096080
• UDI-Public: 00888867096080
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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: 07/31/2019
• Device Model Number: INTERNALBRACE LIGAMENT
• Device Catalogue Number: AR-1688-CP
• Device Lot Number: 10154871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/12/2018
• 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
• Patient Age: 75 YR
• Patient Weight: 64