MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH, PEEK, CS FT, TRI-PLAY, 4.75MM; SCREW, FIXATION, BONE

Model Number	SUTR ANCH, PEEK, CS FT, TRI-PLAY, 4.75MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/09/2019
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 reported during a rotator cuff repair procedure, the ar-1927psf-475 suture anchor peek corkscrew broke upon insertion.The rep stated the tip of the corkscrew was left in the bone, and the remainder of the implant was retrieved by using a grasper.A new hole was drilled by using the ar-1927ptb-475, punch/tap (lot: 011919) and a second ar-1927psf-475 from the same lot was implanted without issue.However, as the surgeon was drilling the new hole the tip of the ar-1927ptb-475 bent.The rep reported nothing broke off from the punch/tap.The retrieved broken portion of the corkscrew and the bent punch/tap will be returning for evaluation.
Additional Manufacturer Narrative
Complaint confirmed.A 7mm long fragment of the anchor was returned.A likely cause for the event is prying and/or leveraging the device during insertion.

• Brand Name: SUTR ANCH, PEEK, CS FT, TRI-PLAY, 4.75MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9254968
• Report Number: 1220246-2019-01381
• Device Sequence Number: 16781766
• Product Code: HWC
• UDI-Device Identifier: 00888867238602
• UDI-Public: 00888867238602
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 06/30/2024
• Device Model Number: SUTR ANCH, PEEK, CS FT, TRI-PLAY, 4.75MM
• Device Catalogue Number: AR-1927PSF-475
• Device Lot Number: 10335608
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/14/2019
• 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