MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK SUTURETAK 3 X 12.2MM; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, PEEK SUTURETAK 3 X 12.2MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 6th march 2025, it was reported by an arthrex employee via email that an ar-1934ps-2, suture anchor, peek suture tak® 3 mm x 12.2 mm with #2 fiberwire® and #2 tigerwire's anchor was stuck during insertion.This was discovered during a repairing of shoulder glenoid labial injury surgery on (b)(6) 2025.The case was completed successfully by using a new ar-1934ps-2.There was no patient harm.
Additional Manufacturer Narrative
Correction: d2a.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-1934ps-2 batch 15122663 was received for investigation.Functional testing was conducted by moving the suture and screw/anchor inside the driver.No issues were found.Visual evaluation found that the peek-optima bio/anchor shows some gouges on the threads.Discoloration spots were noted on the molded handle.The most likely cause(s) of the reported failure are user error, including misalignment of the insertion and improper bone preparation.Directions for use (dfu) dfu-0054-eo bio-fastak, fastak¿, suturetak® and fibertak® suture anchors.G.Precautions.Insert the anchor in the same orientation as the prepared drilled bone hole to avoid damaging the anchor or inserter.Arthrex implant-specific instrumentation must be used to insert implantable devices per the recommended surgical technique.The complaint allegation was confirmed.Refer to the investigation pictures.

• Brand Name: SUTURE ANCHOR, PEEK SUTURETAK 3 X 12.2MM
• 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: 21699709
• Report Number: 1220246-2025-01141
• Device Sequence Number: 20980781
• Product Code: MBI
• UDI-Device Identifier: 00888867024182
• UDI-Public: (01)00888867024182(11)230731(17)280630(10)15122663
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061863
• 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,Followup
• Report Date (Section B): 08/21/2025

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: SUTURE ANCHOR, PEEK SUTURETAK 3 X 12.2MM
• Device Catalogue Number: AR-1934PS-2
• Device Lot Number: 15122663
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: Not provided; 08/21/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/03/2025; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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