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	Wound Dehiscence (1154); Pain (1994)
Date of Event	05/04/2018
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 the patient and was not returned for evaluation.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 achilles debridement and removal of haglunds deformity with a gastric lengthening procedure and there were no issues implanting the achilles speedbridge and amnion.The patient did well post-operatively until 6/4/2018 (4 weeks post-op) when they returned to the clinic with an open wound around the achilles insertion.The surgeon noted that it didn¿t look infected and had it cultured to find out.He notified the rep after the patient¿s appointment and was wondering if there might be an issue with the amnion and/or achilles speedbridge.He requested that they take a further look into it.Surgeon thinks it may be a hematoma that caused the issue but the patient has had no pain until now.The patient is currently going to a wound clinic for a wound vac.Patient has been on aspirin for dvt.The surgeon doesn¿t believe the amnion is the problem and the patient looked good until coming into his clinic on (b)(6) 2018.Patient also had a similar issue with a previous achilles surgery on her right leg.No amnion was used on the right leg when it was done.

• 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: 7629355
• Report Number: 1220246-2018-00524
• Device Sequence Number: 2482131
• Product Code: MAI
• UDI-Device Identifier: 00888867251991
• UDI-Public: 00888867251991
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/22/2018

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 Expiration Date: 05/31/2019
• Device Model Number: IMPLANT SYS, BIOC ACHILLES SPEEDB W/JUMP
• Device Catalogue Number: AR-8928BCJ-CP
• Device Lot Number: 10148633
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 06/22/2018
• 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: 56 YR