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

Catalog Number	AR-8929BC-CP
Health Effect - Clinical Codes	Swelling (2091); Reaction (2414); Fluid Discharge (2686)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Lot number was not provided therefore device history record review was not possible.The contribution of the device to the reported event could not be determined as the device 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 discovered during maude review and reported via medwatch letter (mw5075218) that a patient had reported the following incident: in 2017 patient had surgery to repair patient's left achilles tendon with a new procedure called "achilles midsubstance speedbridge repair.Surgery involved 6 fiberwires from the top of the achilles attached to the lower achilles with no knots and anchored in patient's heel.After 5 months post surgery patient noticed that a blister developed and started to drain on the incision site.Patient's doctor suggested it was infected and prescribed antibiotics for one month.The wound would not stop draining for 3 months.Patient visited doctor again and doctor suggested it was patient's upper skin that was allergic to the fiberwires that was holding patient's achilles together.There are 2 sets of wires, one set on patient's left side of heel and another on the right side.Each set of wires consist of 3 fiberwires.Patient's doctor cut and extracted as far back as she could without going to operating table and stitched patient up.Currently patient reported to be still limping from the wire extraction.Doctor told patient it will take time for tendon to get used to the new tension without the wires.Patient reported that major concern was doctor should have presented patient with a series of complications including a possibility of being allergic to the fiberwires before patient decided to proceed with the new type of surgery.Part number was not provided on maude report.Most likely part number is ar-8929bc-cp.No facility name or contact information was provided on the maude report.Follow up has been sent to patient for additional information.

• 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: 7439292
• Report Number: 1220246-2018-00133
• Device Sequence Number: 1094627
• Product Code: MAI
• UDI-Device Identifier: 00888867131651
• UDI-Public: 00888867131651
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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 Catalogue Number: AR-8929BC-CP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/18/2018
• 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