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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
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 (b)(6) 2024, it was reported by an arthrex employee via email that for an ar-1934ps-2, suture anchor, peek suture tak® 3 mm x 12.2 mm with #2 fiberwire® and #2 tigerwire®, the anchor and suture were pulled out.This was discovered during use in an elbow joint ligament reconstruction surgery on (b)(6) 2024.The case was completed successfully by using another new ar-1934ps-2.There were no broken pieces in the patient.There was no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-1934ps-2 serial/batch number (b)(6) was received for investigation.The device arrived for evaluation accompanied of two sutures.Upon visual inspection, it was observed that the device submitted for evaluation had a screw was broken, small pieces of the screw are attached to the suture.Additionally, the suture appeared to be frayed.The driver was not received for evaluation.The most likely cause for the observed failure is user error for applying excessive force during insertion or through leveraging/prying the device.

• 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: 19546695
• Report Number: 1220246-2024-05856
• Device Sequence Number: 20036625
• Product Code: HWC
• UDI-Device Identifier: 00888867024182
• UDI-Public: 00888867024182
• 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
• Report Date (Section B): 09/24/2024

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 SUTURETAK 3 X 12.2MM
• Device Catalogue Number: AR-1934PS-2
• Device Lot Number: 15144181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2023
• 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