MAUDE Adverse Event Report: ARTHREX, INC. IMPLSYS 2NDRY FIXATN PEEKSWVLK 4.75X19.1; NON-DEGRADABLE FIXATN FASTENER

Model Number	IMPLSYS 2NDRY FIXATN PEEKSWVLK 4.75X19.1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 05-feb-2026, a sales representative reported via email that an ar-1593-p secondary fixation with peek swivelock anchor implant system experienced an issue during a surgical procedure.After drilling and tapping the bone using a larger tap, the peek swivelock anchor fractured upon insertion.The remaining portion of the broken anchor was removed from the bone without complication.The surgeon retapped the site, utilized a new implant, and successfully completed the procedure.There was no reported patient harm.The event occurred during a procedure on (b)(6) 2026.Additional information was received on 11-feb-2026: this was discovered during a root repair procedure.The case was completed using an ar-2324pslc peek-swivelock.The surgery experienced a minimal delay of approximately five minutes.It is unknown whether any additional anesthesia was administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The observed damage to the device was most likely caused by user error, including improper bone preparation, prying, levering, and excessive force.Refer to dfu-0087-eo revision 6.Section g.Precautions.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: IMPLSYS 2NDRY FIXATN PEEKSWVLK 4.75X19.1
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 24416711
• Report Number: 1220246-2026-00872
• Device Sequence Number: 21484734
• Product Code: MBI
• UDI-Device Identifier: 00888867331303
• UDI-Public: (01)00888867331303(11)251006(17)300831(10)15508777
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: IMPLSYS 2NDRY FIXATN PEEKSWVLK 4.75X19.1
• Device Catalogue Number: AR-1593-P
• Device Lot Number: 15508777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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