MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC ADULT CRANIOTOME, LARGE; MOTOR, DRILL, ELECTRIC

Model Number	CRANI-L-G1
Medical Device Problem Codes	Vibration (1674); Device Damaged by Another Device (2915); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: the actual device was returned for evaluation.The craniotome device was evaluated and the reported condition that the device had difficulty removing an attachment and burr device was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the neuro tip of the device was bent/damaged, and the device had vibration.The assignable root cause of these conditions was determined to be traced to component failure due to wear.Udi ¿ (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the craniotome device had a worn bearing, vibration, and the neuro-tip was bent/damaged.It was further determined that the device failed pretest for visual assessment and vibration assessment.It was noted in the service order that the device had difficulty removing an attachment and burr device.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 not reported, however, it was reported that the event occurred in 2022.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: ADULT CRANIOTOME, LARGE
• Common Device Name: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6107428552
• MDR Report Key: 13516929
• Report Number: 1045834-2022-00160
• Device Sequence Number: 19929617
• Product Code: HBC
• UDI-Device Identifier: 00845384016427
• UDI-Public: 00845384016427
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K133604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2022

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: CRANI-L-G1
• Device Catalogue Number: CRANI-L-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown