MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,CRKSCRW
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Joint Swelling (2356)
Date of Event	08/20/2018
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 device remains in the patient.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.
Event or Problem Description
It was reported via e-mail that during a shoulder surgery in (b)(6) 2017 a corkscrew anchor was used.Corkscrew-anchor 6.5mm x 15.5mm, part no.Ar-1925sf.The patient suffers from multiple allergies.Now that the shoulder is reddened and swollen again, the general practitioner needs a "allergy platelet" from arthrex and the detailed material composition of the anchor to exclude an allergic reaction.Update 10sep2018: according to surgeon who performed surgery: no titanium allergy is known, allergy test on the material "peek" was performed.Surgeon cannot provide any further information for data protection reasons.Further information was asked.

• Brand Name: SUTR ANCH,CRKSCRW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7861094
• Report Number: 1220246-2018-00633
• Device Sequence Number: 1633409
• Product Code: HWC
• UDI-Device Identifier: 00888867023192
• UDI-Public: 00888867023192
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2018

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 Model Number: SUTR ANCH,CRKSCRW
• Device Catalogue Number: AR-1925SF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other