MAUDE Adverse Event Report: ARTHREX, INC. STEPPED, RATCHET DRILL SLEEVE; MANUAL INSTR, GENERAL SURGICAL

Model Number	STEPPED, RATCHET DRILL SLEEVE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
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
It was reported that during a cruciate ligament reconstruction surgery the devices ar-1999 (lot: 8002346), ar-1510fs-7 (lot: 051702) and ar-1996cd-1 (lot: 47322249) did not work properly.It was impossible to screw the screw in with the screwdriver, and the tip of the ar-1510fs-7 did not grip the bone.A picture of the device ar-1510fs-7 showed that the front part of the device is damaged/ broken.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device (t-handle wrench).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the reported event was confirmed as one unpackaged ar-1510fs-7 , stepped, ratchet drill sleeve, batch number 051702, was received for investigation and upon visual inspection, it was observed that the tip is heavily damaged (see evaluation pictures 4 + 5).Functional testing was not performed due to the damage of the device.No fragments were returned for evaluation.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the attachment during use.Further the device shows signs of metal surface oxidation an faded laser marks (see evaluation pictures 2 + 3).

• Brand Name: STEPPED, RATCHET DRILL SLEEVE
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24430829
• Report Number: 1220246-2026-00896
• Device Sequence Number: 16009321
• Product Code: MDM
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• 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): 04/23/2026

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: STEPPED, RATCHET DRILL SLEEVE
• Device Catalogue Number: AR-1510FS-7
• Device Lot Number: 051702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown