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

Model Number	SUTURE ANCHOR, PEEK PUSHLOCK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
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 16th january 2025, it was reported by an arthrex employee via email that for an ar-1923ps, suture anchor, peek pushlock® 2.9 x 15.5 mm, the anchor fell off during insertion.This was detected during an ankle ligament repair surgery on (b)(6) 2025.An ar-1923d and ar-1949 was used to prepare bone socket and the anchor fell off during insertion.The patient bone quality was observed to be normal and no fragments were left in the patient.Procedure was successfully completed with no patient harm and no secondary procedure needed by using another new ar-1923ps instead.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is not confirmed.One unpackaged ar-1923ps serial/batch number (b)(6) was received for investigation.Visual inspection noted no issues with the exterior of the device.Both the eyelet and anchor were intact as intended.Additionally, an extra eyelet was returned with the device (not the correct eyelet model for this device).Functional testing was not performed as it is irrelevant to the allegation.No problem found.

• Brand Name: SUTURE ANCHOR, PEEK PUSHLOCK
• 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: 21313647
• Report Number: 1220246-2025-00203
• Device Sequence Number: 8151123
• Product Code: HWC
• UDI-Device Identifier: 00888867023147
• UDI-Public: (01)00888867023147(11)231129(17)281031(10)15173908
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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 PUSHLOCK
• Device Catalogue Number: AR-1923PS
• Device Lot Number: 15173908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2023
• 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