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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff surgery the metal part from anchor broke down and was left inside the anchor.All parts were retrieved.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-1927psf-3 sutr anch, peek crkscrw ft, tri-play serial/batch number (b)(6) was received for evaluation.Functional testing was not performed because the device was received damaged.The visual evaluation found tip of the driver was broken off and it was found lodged on the peek screw.The evaluation of the screw noted damage on the threads as warped.No damage on the suture was observed.The most likely cause of the reported failure is improper misaligned insertion, prying, or leveraging 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: jared engle ; 8009337001
• MDR Report Key: 20589780
• Report Number: 1220246-2024-08375
• Device Sequence Number: 15652785
• Product Code: MBI
• UDI-Device Identifier: 00888867023642
• UDI-Public: (01)00888867023642(11)240226(17)290131(10)15212258
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: 15212258
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2024
• 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