MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK CORKSCREW; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, PEEK CORKSCREW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 25th march 2024, it was reported by a sales rep.Via email that for an ar-1927pnf-45, 4.5 mm peek corkscrew® ft suture anchor with four needles with one #1 fiberwire® and one #1 tigerwire®, the nurse stated that the tip of the corkscrew anchor broke off when mr.Coleman was screwing it into the bone.The sales rep asked her if all the correct sets were followed to put the anchor and in her knowledge it was.There was no support at the case.This was detected during use in a rotator cuff repair procedure on (b)(6) 2024.The procedure was completed successfully as the broken pieces were removed and a new anchor was inserted.
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.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion of the anchor.

• Brand Name: SUTURE ANCHOR, PEEK CORKSCREW
• Common Device Name: BONE FIXATION SCREW/PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19032431
• Report Number: 1220246-2024-01795
• Device Sequence Number: 7068794
• Product Code: HWC
• UDI-Device Identifier: 00888867023611
• UDI-Public: 00888867023611
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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 Model Number: SUTURE ANCHOR, PEEK CORKSCREW
• Device Catalogue Number: AR-1927PNF-45
• Device Lot Number: 15083610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown