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

Model Number	SUTURE ANCHOR, CORKSCREW FT II
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Tingling (2171); Discomfort (2330)
Date of Event	10/10/2019
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was previously reported by a patient (case (b)(4)) that the patient had undergone a left hamstring tendon repair 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 433344, corkscrew ft ii suture anchor and ar-18928sf-2, lot 388268), suture anchor, corkscrew, ft ii).The patient reported that he had been experiencing 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 had increased with constant discomfort in the hip bone.Patient had been treated with physical therapy and drugs.At time of initial report patient stated he may have developed an allergy to the metal.Medwatch reports (1220246-2019-00942 and 1220246-2019-00943) were submitted for the possible allergic reaction.Additional information obtained 10/15/19: the patient has reported that he underwent a second surgery on (b)(6) 2019 to explant the two anchors (ar-1928snf-2, lot 433344, corkscrew ft ii suture anchor and ar-18928sf-2, lot 388268), which were previously implanted during the (b)(6) 2012 procedure.The anchors had been intended to hold his hamstring in place while it reattached to his pelvic bone.These anchors were removed and not replaced.Patient had requested to keep the explanted anchors but the facility declined to do so, being told it was due to the sharpness of the device.Final disposition of the anchors by the facility is unknown.

• 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: 9289953
• Report Number: 1220246-2019-01407
• Device Sequence Number: 1724330
• Product Code: HWC
• UDI-Device Identifier: 00888867023703
• UDI-Public: 00888867023703
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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: 10/15/2019
• Initial Report FDA Received Date: 11/07/2019
• 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: 67 YR