MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 6.5CM ADULT CRANI ATTACHMT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	CRANI-A
Medical Device Problem Codes	Vibration (1674); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service and evaluation, it was determined that the craniotome device neuro tip was bent/damaged.It was noted in the service order that the device had vibration.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2025.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: a visual and functional assessment was performed: the following steps failed: verification: visual assessment: (check the overall condition of the unit.) verification: lock operation: (uut should lock and release easily.) verification: cutter insertion: (cutter should go through easily) during service/repair the following was observed: dural guard scratch, motor connection snagged, bar insertion inability (bearing falling off) during the service evaluation the following failures were identified: visual : craniotome neuro-tip bent/damaged device interaction (2+ devices) : difficult to assemble/disassemble device interaction (2+ devices) : cannot insert cutter visual : bearing damaged conclusion: ¿ failure reported is not confirmed ¿ root cause: component wear ¿ action: repair.

• Brand Name: 6.5CM ADULT CRANI ATTACHMT
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: elba bello ; 4500 riverside drive; palm beach gardens, FL 33410 ; 9083863534
• MDR Report Key: 23973537
• Report Number: 1045834-2026-00004
• Device Sequence Number: 18408083
• Product Code: ERL
• UDI-Device Identifier: 00845384001720
• UDI-Public: (01)00845384001720
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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 Catalogue Number: CRANI-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown