MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP
Health Effect - Clinical Codes	Inflammation (1932); Reaction (2414)
Date of Event	06/20/2018
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 remains in patient and was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
It was reported that the patient underwent an achilles tendon repair procedure on (b)(6) 2018.The case went smooth.The surgeon removed the bone spurs and used an achilles speedbridge, ar-8928bcj-cp, to repair the achilles tendon.The surgeon then used aflex201 for additional reinforcement of the achilles.Four months post-op, the patient is showing an inflammatory reaction at the surgical site.There is also bone distraction as well.The surgeon put the patient into the hospital for a bone biopsy and three phase bone scan to differentiate between an implant reaction or osteomyelitis.Additional information provided 6/26/2018: the surgeon has only removed the aflex only at this point (removed on (b)(6) 2018).The patient was admitted into the hospital and stayed a total of 5 days.No photos of the reaction were taken.

• Brand Name: IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7684938
• Report Number: 1220246-2018-00540
• Device Sequence Number: 13802567
• Product Code: MAI
• UDI-Device Identifier: 00888867251991
• UDI-Public: 00888867251991
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

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: No Information
• Device Model Number: IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP
• Device Catalogue Number: AR-8928BCJ-CP
• Device Lot Number: 10146222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/13/2018
• 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