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	Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Swelling (2091); Cramp(s) (2193)
Date of Event	03/05/2020
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 by the patient that she had undergone a haglunds and achilles procedure on her foot on (b)(6) 2018.Her medical records note that the surgeon had implanted an arthrex speedbridge implant, ar-8928bc-cp.Patient has a known allergy to latex and surgeon also noted in her records that her implant needed to be a metal composition.Patient also disclosed that sometime in her past she has experienced issues when wearing costume jewelry and so has since avoided such jewelry.Since the surgery the patient has developed numerous issues in her foot.The foot is swollen with what appears to be a large growth.She has a stinging/ pins and needles feeling in the top of foot and has developed what looks similar to a psoriasis type outbreak on the bottom of her foot.She continually has leg cramps at night and when stepping out of bed has a tremendous amount of pain in her foot.She has undergone a year of intense therapy to help with the hypersensitivity issues she is also experiencing but although some relief the issues have continually gotten worse since the surgery.The patient has requested the material composition of the implant components which will be provided to her.The patient medical records also noted an amino tissue from active sky matrix on the tissue log indicating that she may have received some sort of tissue bank product during the surgery as well.

• 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: 9883039
• Report Number: 1220246-2020-01767
• Device Sequence Number: 2784740
• Product Code: MAI
• UDI-Device Identifier: 00888867049123
• UDI-Public: 00888867049123
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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 Model Number: IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
• Device Catalogue Number: AR-8928BC-CP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other