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

Model Number	SUTURE ANCHOR, CORKSCREW FT II
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/06/2018
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.The device was reported to have been discarded by the facility.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a rotator cuff revision procedure, the surgeon punched the bone with a 4.5mm punch and attempted to insert a 6.5mm bio-composite corkscrew anchor.The anchor cracked and broke within two turns.A second 6.5mm bio-composite corkscrew anchor was opened and again, the surgeon attempted to insert it into the 4.5mm hole.The anchor cracked and then broke within two turns.All fragments of the broken anchors were retrieved and the case was completed with titanium corkscrews instead.Additional information provided 6/19/2018: during the revision the surgeon explanted two ar-1928sf-2, 5.5 mm titanium corkscrews, that were implanted during the original surgery.The revision surgery was being performed due to a failed rotator cuff repair.The primary anchors were still securely fixated in the humeral head and it was reported that an exact cause of failure was not apparent.The surgeon indicated to the sales rep that the patient was non-compliant postoperatively.The original procedure had been performed by the same surgeon on (b)(6) 2016 at a different facility than the revision.

• 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: 7685052
• Report Number: 1220246-2018-00541
• Device Sequence Number: 13802323
• Product Code: HWC
• UDI-Device Identifier: 00888867023703
• UDI-Public: 00888867023703
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

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: No Information
• Device Expiration Date: 04/30/2020
• Device Model Number: SUTURE ANCHOR, CORKSCREW FT II
• Device Catalogue Number: AR-1928SF-2
• Device Lot Number: 1240829
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 07/13/2018
• 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