MAUDE Adverse Event Report: ARTHREX, INC. PARS SUTURE IMPLANT KIT W/ SUTURETAPE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	PARS SUTURE IMPLANT KIT W/ SUTURETAPE
Health Effect - Clinical Codes	Inflammation (1932); Fluid Discharge (2686)
Date of Event	01/15/2016
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.Device was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
Original date of surgery (b)(6) 2019.Mid substance achilles rupture.The surgeon states that the sutures are coming out at the site.He wanted the rep to inquire if we have had previous instances of this.Rep is unsure what the surgeon will be doing about this.Patient is male, unknown age.Additional information obtained 3/7/2019: the patient underwent a pars mid-substance repair procedure.The incision healed and the sutures began to protrude through the patient's skin at the distal anchor site.The surgeon has performed a revision procedure to remove the anchors and the connected suture from the patient.The surgeon found the achilles looks good after the repair.Patient has no known allergies and is not diabetic.No photos were available to provide.Sales rep stated the surgeon indicated to him that he believes there is some sort of inflammatory response to the anchors, as the wound initially healed and then appeared to become full of pus and is soft to the touch before it opened up and began to spit out the suture.Date of revision is unknown at this time.Additional information obtained 3/21/19: the surgeon has personally provided corrected surgeries dates.Original date of surgery was (b)(6) 2015 with removal surgery on (b)(6) 2016 of both the anchor and fiberwire.Surgeon stated he attempted to remove all pieces.

• Brand Name: PARS SUTURE IMPLANT KIT W/ SUTURETAPE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8440494
• Report Number: 1220246-2019-00978
• Device Sequence Number: 2926663
• Product Code: GAT
• UDI-Device Identifier: 00888867288263
• UDI-Public: 00888867288263
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K171296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2019

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 Model Number: PARS SUTURE IMPLANT KIT W/ SUTURETAPE
• Device Catalogue Number: AR-8862DS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/21/2019
• 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