MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)
Date of Event	06/25/2019
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 device was reported to have been discarded.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 on (b)(6) 2019 the patient underwent an achilles repair procedure where a bio-composite achilles mid-substance implant system, ar-8929bc-cp, was implanted.Two weeks after the surgery, the patient began to experience allergic reaction-like eruption in their skin.The affected area had repeated blisters, rashes and ruptures which were initially recognized throughout the body, but were gradually confined to the wound area.A revision procedure took place on (b)(6) 2019 where the surgeon explanted the implant.A patch test was performed on the extracted product and a positive reaction was observed.The patient was seen on (b)(6) 2019 and it was reported that the patient's condition after removal was good.

• Brand Name: IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9081172
• Report Number: 1220246-2019-01321
• Device Sequence Number: 2774482
• Product Code: MAI
• UDI-Device Identifier: 00888867131651
• UDI-Public: 00888867131651
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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 Model Number: IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE
• Device Catalogue Number: AR-8929BC-CP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/18/2019
• 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