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

Catalog Number	CRANI-P-G1
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that the footplate of the craniotome device was bent.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.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 november of 2024 all available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.Corresponding complaint device.
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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.A review of the device history was performed and no non-conformances were detected related to the reported condition.
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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed, and the reported condition that the craniotome footplate was bent was not confirmed.Therefore, assignable root cause was not determined.However, it was determined that the nose tube was bent/damaged, the locking mechanism was bent/stuck, the cutter could not be inserted, and the device had vibration.It was further determined that the device failed pretest for visual assessment, cutter insertion assessment, lock operation assessment, and vibration assessment.The assignable root cause of these conditions was determined to be traced to the user, which is user error.
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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: correction h6: it was inadvertently reported that the reported condition of the crani-p-g1 footplate was bent was not confirmed.Please note that the investigation summary has been updated to confirmed.Updated investigation summary: the actual device was returned for evaluation.During repair, an evaluation was performed, and the reported condition that the craniotome footplate was bent was confirmed.An assessment was performed and it was determined that the nose tube was bent/damaged, the locking mechanism was stiff/stuck, the cutter could not be inserted, and the device had vibration.It was further determined that the device failed pretest for visual assessment, cutter insertion assessment, lock operation assessment, and vibration assessment.The assignable root cause of these conditions was determined to be traced to the user, which is user error.

• Brand Name: PEDIATRIC CRANIOTOME
• Common Device Name: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 20850202
• Report Number: 1045834-2024-01128
• Device Sequence Number: 11741705
• Product Code: HBC
• UDI-Device Identifier: 00845384016403
• UDI-Public: (01)00845384016403
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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-P-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/21/2025; 02/12/2025; 02/13/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/21/2025; 02/12/2025; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2014
• 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