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

Catalog Number	AR-8928P-CP
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Impaired Healing (2378)
Date of Event	04/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, weight) were requested but not provided.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.The device was not returned for evaluation but remained in the patient 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.Lot number was not provided so device history record review cannot be performed.If additional relevant information is received, a follow-up report will be submitted.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.Part remains in patient.
Event or Problem Description
It was reported by the patient via email that an arthrex speedbridge was implanted after an achilles rupture about a year prior ((b)(6) 2016).Patient has been suffering from wound healing disorder and pain since the surgery.On about (b)(6) 2017, anchor got loose when the wound was being cleaned / disinfected.Wound also is inflamed.Part number was confirmed to be the achilles speedbridge.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, weight) were requested but not provided.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.This is a follow-up submission due to a correction to the device's part and lot number.The device was not returned for evaluation but remained in the patient 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.Lot number was not provided so device history record review cannot be performed.If additional relevant information is received, a follow-up report will be submitted.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.Part remains in patient.
Event or Problem Description
It was reported by the patient via email that an arthrex speedbridge was implanted after an achilles rupture about a year prior (~ (b)(6) 2016).Patient has been suffering from wound healing disorder and pain since the surgery.On about (b)(6) 2017, anchor got loose when the wound was being cleaned / disinfected.Wound also is inflamed.Part number was confirmed to be the achilles speedbridge.

• Brand Name: IMPL SYS,PEEK 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: 6580999
• Report Number: 1220246-2017-00177
• Device Sequence Number: 10791986
• Product Code: MAI
• UDI-Device Identifier: 00888867131651
• UDI-Public: 00888867131651
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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: 02/01/2021
• Device Catalogue Number: AR-8928P-CP
• Device Lot Number: 10031071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 06/09/2017
• 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