MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT III; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,CRKSCRW FT III
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported during a rotator cuff repair procedure, the surgeon inserted ar-1928sf-3 lot: 13256588 suture anchor, into the humerus as he was screwing down the suture anchor the implant broke in half.The surgeon used a second ar-1928sf-3, same lot number and the same issue occurred.All broken fragment were removed.The surgeon used a punch and tap in the same insertion site, the case was completed by inserting 2-additional ar-1928sf-3 suture anchors different lot numbers.
Additional Manufacturer Narrative
Complaint confirmed.Two unpackaged ar-1928sf-3 devices were received for investigation.Visual inspection identified that only two threads remained along the first of the returned ar-1928sf-3 driver, and the corkscrew anchor at the distal end of the second driver had split at the third thread.It was reported that the bone quality encountered was "hard", and it was relayed that no bone preparation had been used.The observed condition is consistent with inadequate bone preparation prior to use.

• Brand Name: SUTR ANCH,CRKSCRW FT III
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12333137
• Report Number: 1220246-2021-03523
• Device Sequence Number: 4068049
• Product Code: HWC
• UDI-Device Identifier: 00888867023727
• UDI-Public: 00888867023727
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: SUTR ANCH,CRKSCRW FT III
• Device Catalogue Number: AR-1928SF-3
• Device Lot Number: 13256588
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1