MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, CORKSCREW FT II; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, CORKSCREW FT II
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Excessive Tear Production (2235); Discomfort (2330)
Date of Event	07/25/2012
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.The device remains in the patient.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported by a patient, via the arthrex website, that the patient had undergone a procedure on (b)(6) 2012.The patient had torn his hamstring off the pelvic bone and the surgeon reattached it using two arthrex anchors, ar-1928snf-2 (lot 388266).Patient states he may have developed an allergy to the metal.Patient has requested material composition of the anchors and has also requested the type of head that would be on the anchor and what instrument his current orthopedic surgeon will need to remove the anchors.The requested information will be provided to the patient.The part and lot number provided by the patient are not a valid match.Additional information has been requested from the patient.Additional information obtained 2/15/19: per the surgery implant log, the two devices implanted during the (b)(6) 2012 procedure were: ar-1928snf-2, lot 433344, corkscrew ft ii suture anchor.Ar-18928sf-2, lot 388268, suture anchor,, corkscrew, ft ii 5.5mm.The (b)(6) 2012 procedure was a left hamstring tendon repair.The patient's symptoms include pain in pelvic bone and entire leg, tenderness and swelling in entire hip and leg.The symptoms began a few months after surgery when it was noticed the patient still had swelling which had not dissipated.Over time discomfort started with tingling in the leg and through the years the pain and swelling has in creased with constant discomfort in the hip bone.Patient has been treated with physical therapy and drugs.Patient does not have a current orthopedic surgeon but is seeking one who can remove the anchors.

• Brand Name: SUTURE ANCHOR, CORKSCREW FT II
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8391556
• Report Number: 1220246-2019-00946
• Device Sequence Number: 1651606
• Product Code: HWC
• UDI-Device Identifier: 00888867023703
• UDI-Public: 00888867023703
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

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: 03/31/2016
• Device Model Number: SUTURE ANCHOR, CORKSCREW FT II
• Device Catalogue Number: AR-1928SF-2
• Device Lot Number: 388266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/05/2019
• 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
• Patient Age: 60 YR