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

Model Number	STEPPED, RATCHET DRILL SLEEVE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2026, it was reported via email that an ar-1510fs-7, stepped ratchet drill sleeve was reported to be unusable in a case.This occurred on (b)(6) 2024 during a left knee meniscal root repair.It was reported that after drilling with the k-wire to have the reverse reamer working, the surgeon was informed by the representative that the reverse reamer was not working.As such the surgeon could not proceed to put the suture into the posterior root of the meniscus and put it through into the drilled part of the bone.This appears to have been due to the drill sleeve being bent and not allowing the flipcutter through.The case was not completed successfully as no alternative drill sleeve or flipcutter was available to be used.There was case involvement.
Additional Manufacturer Narrative
Additional information: d4, g3.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6 the complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, resulting from one or more of the following factors: 1.Instrument damage caused by inadvertent mechanical impact during setup, assembly, handling, or inspection.2.Mechanical deformation resulting from improper handling during cleaning or reprocessing cycles.3.Material stress or deformation caused by improper storage, transport, or stacking of instruments.Directions for use dfu-0023-eo revision 5, instruments e.Inspection and maintenance 1.Arthrex non-sterile devices are precision medical devices and must be used and handled with care.Inspect the devices for damage prior to use, and at all stages of handling thereafter.If damage is detected, do not use the device prior to consulting the manufacturer for guidance.I.Cautions 2.To avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.4.Instruments with adjustable components must be handled with care.Overtightening or rough handling of the instrument may damage the locking mechanism.Locking mechanisms with internal polymer components may become weakened after repeated autoclaving.The complaint allegation was confirmed upon reviewing the customer¿s attached pictures.The images showed an ar 1510fs 7 ratcheting drill sleeve for flipcutter®, stepped, 3.5 mm, with an unknown batch number.The tip was visibly bent in multiple areas, and numerous scratches were observed along the shaft.
Event or Problem Description
Additional info received on 3/04/2026: the sales representative noticed the flip-cutter sleeve was bent when the tray was opened so informed the doctor and they did not attempt to use it during the case.

• 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 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24413880
• Report Number: 1220246-2026-00861
• Device Sequence Number: 14931780
• Product Code: MDM
• UDI-Device Identifier: 00888867196766
• UDI-Public: 00888867196766
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 03/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: STEPPED, RATCHET DRILL SLEEVE
• Device Catalogue Number: AR-1510FS-7
• Device Lot Number: 151932
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 03/20/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/10/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown