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 Code	Rash (2033)
Date of Event	03/19/2020
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
It was reported that the patient had a reaction to the implant that was inserted on (b)(6) 2019 to repair achilles tendon; also at the time was a removal of a bone spur.The patient ( female (b)(6)) had blisters all over her foot; she went to a dermatologist and was given a topical that did not improve the problem.On (b)(6) she visited the original doctor with a rash at the site.That doctor gave her an antibiotic ointment which did not improve the problem; she returned to the dermatologist who gave her steroid injections and cream and the site has improved.Her last visit to the original doctor was (b)(6) 2020 and showed an improvement at the site.

• 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: 9935576
• Report Number: 1220246-2020-01786
• Device Sequence Number: 754619
• Product Code: MAI
• UDI-Device Identifier: 00888867049123
• UDI-Public: 00888867049123
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
• Device Catalogue Number: AR-8928BC-CP
• Device Lot Number: 10220981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 04/08/2020
• 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: 65 YR