MAUDE Adverse Event Report: ARTHREX, INC. KERRISON, 6.0 X 260MM, 40°; SURGICAL PUNCH

Model Number	KERRISON, 6.0 X 260MM, 40°
Medical Device Problem Code	Material Fragmentation (1261)
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
It was reported that during a surgery black metal abrasion was produced.Per complaint reporter there was no harm for patient, operator or third party.No further information received.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.The reported event was not confirmed.One unpackaged ar-s7440-060-260, kerrison, 6.0 x 260mm, 40°, batch number 01577552r, was received for investigation and upon visual inspection, no metal abrasion could be observed.However, small scratches were found in the ceramic coating at the shaft and at the distal end.No fragments were returned for evaluation.The most likely cause of the reported failure can be attributed to normal wear and tear resulting from repetitive use of the device.
Event or Problem Description
Update 02-mar-26: further information was received on 23-feb-26 that no parts remained inside the patient.A spinal disc surgery was performed.The surgery was finished successfully with a new device from the set.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: KERRISON, 6.0 X 260MM, 40°
• Common Device Name: SURGICAL PUNCH
• 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: 24405293
• Report Number: 1220246-2026-00715
• Device Sequence Number: 15528811
• Product Code: LXH
• UDI-Device Identifier: 04049197515696
• UDI-Public: (01)04049197515696(11)231011(10)01577552R
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/26/2026

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: KERRISON, 6.0 X 260MM, 40°
• Device Catalogue Number: AR-S7440-060-260
• Device Lot Number: 01577552R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 05/26/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/23/2026; 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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