MAUDE Adverse Event Report: ARTHREX, INC. #2 FIBERSTICK, #2 FIBERWIRE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	#2 FIBERSTICK, #2 FIBERWIRE
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Urticaria (2278); Reaction (2414); Patient Problem/Medical Problem (2688)
Date of Event	10/31/2014
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 therefore the complainant's event could not be verified.The root 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.Patient sensitivity to materials must be considered prior to implantation.Arthrex¿s directions for use packaged with the fiberwire® suture states that silicone sensitivity, though very rare, has been reported.
Event or Problem Description
It was originally reported that the patient had suffered a shoulder injury in 2011 while working.On (b)(6) 2013 she underwent a shoulder procedure during which an arthrex ar-7209, lot :10667 (#2 fiberstick, #2 fiberwire) and an ar-7200 lot: unknown (fiberwire braided pb #2 suture, blue w/needle) were utilized.Following the (b)(6) 2013 surgery the patient began to experience reaction type symptoms which the patient reported to arthrex on (b)(6) 2014 ((b)(4), medwatch 1220246-2014-00200).At that time the patient reported that she had been having hives with a possible reaction to the fiberwire.The patient also reported that she had been seen by a dermatologist but the outcome had been inconclusive at that time.No further information was provided to arthrex.On january 9, 2019, arthrex received a cd from the patient containing voluminous medical records.The medical records note the patient continued to have issues following her (b)(6) 2013 right shoulder surgery including anaphylactic shock episodes, angioedema and urticaria.The patient was seen by multiple medical professionals to determine what was causing her frequent episodes of anaphylaxis.It was identified via a patch testing of the fiberwire by a dermatologist that the arthrex fiberwire suture used in her shoulder may be causing these reactions.Although the results were inconclusive, a removal surgery was recommended.On (b)(6) 2014, the patient underwent a revision surgery to remove the fiberwire suture.According to the patient¿s medical records, following the removal surgery, the anaphylactic shock condition has subsided and no new episodes have occurred since the removal.The records also indicate that ¿things that make this condition worse are certain things she touches such as silicon¿.Although the patient is no longer suffering reaction symptoms she is still having issues with her shoulder.

• Brand Name: #2 FIBERSTICK, #2 FIBERWIRE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8321453
• Report Number: 1220246-2019-00887
• Device Sequence Number: 19255550
• Product Code: GAT
• UDI-Device Identifier: 00888867041370
• UDI-Public: 00888867041370
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

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 Expiration Date: 04/30/2018
• Device Model Number: #2 FIBERSTICK, #2 FIBERWIRE
• Device Catalogue Number: AR-7209
• Device Lot Number: 10667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR