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

Model Number	IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erythema (1840); Fever (1858); Nausea (1970); Pain (1994)
Date of Event	05/01/2018
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.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
An initial claim notice was received from the patient's attorney in (b)(6) 2018.No part numbers or incident information was provided at that time to confirm an arthrex product was involved.On (b)(6) 2019, the patient's legal representative provided medical records which reported the patient underwent a haglund's osteotomy, gastroc recession (left) on (b)(6) 2016.During the 2016 procedure, an arthrex ar-8928bc-cp, lot 10061945 (implant system, bio-composite achilles speedbridge) device was implanted.The patient reported significant improvement in pain until injuring his foot.The medical records note the patient was doing well post-surgery; however, the patient had an open ¿dehiscence¿ of the distal wound for over a year that went unresolved.The patient still used lidocaine patches but had stopped taking gabapentin.On (b)(6) 2018, the patient was admitted to the er for pain after developing a new opening along the distal incision.The patient went to the er when the wound on his heal re-opened.Er records note that the patient reported pain in his ankle and heel, increased fever, nausea, and increased redness to the heal.A ct of his ankle noted osteomyelitis of the calcaneus.The patient was admitted for further evaluation and treatment.Wound care was ordered; the podiatrist performed an incision and drainage, debridement of the calcaneus, and removed the hardware from his left foot on (b)(6) 2018.Bone pathologies and culture swabs were performed and the cultures were positive for staph.

• Brand Name: IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8317219
• Report Number: 1220246-2019-00886
• Device Sequence Number: 11138168
• Product Code: MAI
• UDI-Device Identifier: 00888867049123
• UDI-Public: 00888867049123
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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 Expiration Date: 08/31/2018
• Device Model Number: IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
• Device Catalogue Number: AR-8928BC-CP
• Device Lot Number: 10061945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 48 YR
• Patient Weight: 115