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	Inflammation (1932); Pain (1994)
Date of Event	05/02/2016
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 reported by the patient that on (b)(6) 2016 a labrum-fixation with fibertak 1.5 tigerwire was performed with patient.Since this surgery she suffers from invalidating pain, especially in the area of the suprascapular nerve and the brachial plexus.Update 22-feb-2019: the patient was operated for a simple slap (superior labrum from anterior to posterior) lesion with biceps tenodesis (1x corkscrew) and refixation of the post labrum with 2 fibertak`s.Post-op the patient showed classic residual symptoms like a capsulitis.Even though the patient showed signs of capsulitis, the surgeon does not think that it is caused by the arthrex device.According to the surgeon the patient is hyperreactive and extremely skeptical.In the meantime, she has been re-operated twice by different hospitals/surgeons.According to the patient after each surgery it gets worse.Update 11-mar-2019: the following items were involved in the surgery on (b)(6) 2016: two pieces ar-1928sf-2-1, lot number: 759948 and 759948.Three pieces of ar-3600 lot numbers: 1552643 ; 1552643 ; 300375.

• 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: 8464084
• Report Number: 1220246-2019-00990
• Device Sequence Number: 11097998
• Product Code: HWC
• UDI-Device Identifier: 00888867023710
• UDI-Public: 00888867023710
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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, CORKSCREW FT II
• Device Catalogue Number: AR-1928SF-2-1
• Device Lot Number: 759948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/29/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other