MAUDE Adverse Event Report: ARTHREX INC. 4-0 FIBERLOOP, 20 INCHES WITH NEEDLE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	AR-7229-20
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Burning Sensation (2146); Reaction (2414)
Date of Event	01/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, 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.Lot number was not provided so device history record review cannot be performed.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation 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.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.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that patient had prior surgery which resulted in a patient reaction to the sutures that were used.The prior surgery was on (b)(6) 2017.It was a left thumb cmc arthroplasty.Sutures used in the prior surgery were ulnar capsule suture 4-0 supramid (s.Jackson) and subcuticular suture 4-0 prolene (j&j).No arthrex products were used during this prior surgery.Reaction symptoms began within 7-10 days of prior surgery.Reaction was inflammation, heat and a burning feeling.No pain was involved in the reaction from this prior surgery.Patient was put on antibiotics as a precaution, but symptoms subsided upon removing the sutures at 14 days post op.Around 7 months post joint replacement patient began having pain in the joint.At that time it was determined patient had a prominent osteophyte and potential fcr tendonitis.Surgery was scheduled and performed (b)(6) 2018, 11 months after the prior surgery that resulted in a reaction to the sutures.The second surgery was a left thumb trapezial osteophyte reaction and left thumb fcr tenotomy.Patient received another manufacturer's implant (skeletal dynamics) during the (b)(6) 2018 surgery.Sutures used during the (b)(6) 2018 surgery were: ulnar capsule suture which was an ar-7299-##, 4-0 fiberloop (arthrex) and subcuticular suture which was a 4-0 monocryl (ethicon).Following the second surgery the patient had a local reaction again at 7-10 days.This time it progressed and worsened.In addition to the local reaction the patient had a much deeper tissue reaction with inflammatory response including extreme pain.The reaction continues to date but cycles through visibly worse days and noticeably calmer days.However pain is always present.Patient has requested material composition of product and any specific coating, preservative, sterilization method, etc.That is used in the preparation of the fiberloop suture to try and rule out an adverse event to any of the materials.M follow-up investigation: ar-7229-20 this part number has been determined to be the most likely part number based on facility purchases of ar-7229 devices.

• Brand Name: 4-0 FIBERLOOP, 20 INCHES WITH NEEDLE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7439304
• Report Number: 1220246-2018-00145
• Device Sequence Number: 1055119
• Product Code: GAT
• UDI-Device Identifier: 00888867041608
• UDI-Public: 00888867041608
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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 Catalogue Number: AR-7229-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/18/2018
• 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