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

Model Number	SUTR ANCH,CRKSCRW
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2020
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.
Event or Problem Description
It was reported that during a reinsertion of the pectoralis major tendon surgery the threads of ar-1915snf-1 broke during suturing.Surgeon wanted to use corkscrew 3.5mm open needle anchors.One of the three anchors of this size placed broke during insertion between the body of the screw and the eyelet for passing the threads.With one other the two threads broke when tightening the knots.Then the surgeon took the corkscrew 5.5 with reinforced threads but at the first, the support screwdriver broke before the screw was completely inserted.Surgeon tried to screw it in despite of everything but without success and the two threads were very damaged.Only the metal core remained.Surgeon finished the surgery with removing it to drill at 4.5mm before inserting a new screwed anchor.In the end, there are four anchors in the patient´s humerus, two of them are unnecessary.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1915snf-1 drive assembly was received for investigation.Visual inspection identified that the corkscrew anchor had broken off of the distal tip of the drive assembly.The fragment generated during the event was not returned for review.A suture fragment was returned with the drive assembly, and it was noted that the hook at the end of the suture construct was intact.Material analysis of the drive shaft was conducted and testing concluded that the device met all as-received specifications.As such, the observed condition of the returned drive assembly is consistent with prying/leveraging the device during insertion.

• Brand Name: SUTR ANCH,CRKSCRW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11119637
• Report Number: 1220246-2021-02450
• Device Sequence Number: 14433955
• Product Code: HWC
• UDI-Device Identifier: 00888867022683
• UDI-Public: 00888867022683
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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: 05/31/2025
• Device Model Number: SUTR ANCH,CRKSCRW
• Device Catalogue Number: AR-1915SNF-1
• Device Lot Number: 11081441
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 04/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other