MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK SUTURETAK 2.4X12.4MM; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, PEEK SUTURETAK 2.4X12.4MM
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Reaction (2414)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the devices were not returned for evaluation therefore the complainant's event could not be verified.The devices remain in the patient.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.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.
Event or Problem Description
It was reported that after having an ar-1938ps, suture anchor peek suture tak (lot: unknown) and ar-ar-1934pf-24, 2.4 mm peek suturetak (lot: unknown) implanted on (b)(6) 2017 the patient started to experience an adverse reaction approximately two to three weeks post-op.The patent was experiencing an itchy rash with small red dots on their back, arms, hands, thighs, "calfs", top of feet, chest and stomach.The patient informed their surgeon of their symptoms at their six week post-op appointment.Allergy scratch and patch testing was performed, and the results revealed a sulfite sensitivity.The patient went on a sulfite free diet for two months, but the symptoms were still present.The patient has been seeing dermatologists and allergists to try and resolve the issue.The patient has been prescribed prednisone to treat symptoms.

• Brand Name: SUTURE ANCHOR, PEEK SUTURETAK 2.4X12.4MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8288730
• Report Number: 1220246-2019-00868
• Device Sequence Number: 1947285
• Product Code: HWC
• UDI-Device Identifier: 00888867024120
• UDI-Public: 00888867024120
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• 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): 01/30/2019

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: SUTURE ANCHOR, PEEK SUTURETAK 2.4X12.4MM
• Device Catalogue Number: AR-1934PF-24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/30/2019
• 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