MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
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
On 01/04/2024, it was reported by a arthrex employee via email that an ar-1927psf-3 suture anchor shaft is damaged.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection identified the threads of the suture anchor, peek corkscrew® ft, tripleplay®,5.5 x 14.7 mm with two #2 fiberwire® and one #2 tigerwire® had warped.Functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
• 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: emily shafer ; 8009337001
• MDR Report Key: 18565345
• Report Number: 1220246-2024-00487
• Device Sequence Number: 20878697
• Product Code: MBI
• UDI-Device Identifier: 00888867023642
• UDI-Public: 00888867023642
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K143745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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: SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
• Device Catalogue Number: AR-1927PSF-3
• Device Lot Number: 15057112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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