MAUDE Adverse Event Report: THE ANSPACH EFFORT LLC 6.5CM PEDIATRIC CRANIOTOME; MOTOR, DRILL, ELECTRIC - CRANIOTOME

Catalog Number	CRANI-P
Medical Device Problem Codes	Vibration (1674); Device Damaged by Another Device (2915); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.H10 additional narrative: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device is being further investigated.Once the investigation has been completed, a supplemental medwatch will be submitted.D4: udi: (b)(4).
Event or Problem Description
It was reported from japan that during service and repair/pre-testing, it was observed that the craniotome device overheated, it was difficult to attach it to the motor device, was vibrating, the bearing was worn and the device was bent.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2024.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.H10 additional narrative: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.An evaluation was performed and it was determined that the device heated up, the bearing was worn, the neuro tip was damaged, vibrated and was difficult to assemble and disassemble.Therefore, the reported condition was confirmed.The assignable root cause was traced to component failure due to normal wear.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.H10 additional narrative: it was further observed that the device dural guard was broken, the motor connection and bar were snagging, made an abnormal noise, was vibrating and generated heat.The device also failed pretests for visual assessment, lock operation, cutter insertion, vibration and temperature assessment.H4: the date of manufacture has been added.

• Brand Name: 6.5CM PEDIATRIC CRANIOTOME
• Common Device Name: MOTOR, DRILL, ELECTRIC - CRANIOTOME
• Manufacturer (Section D): THE ANSPACH EFFORT 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: 19143281
• Report Number: 1045834-2024-00401
• Device Sequence Number: 7834053
• Product Code: HBC
• UDI-Device Identifier: 00845384001775
• UDI-Public: 00845384001775
• 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,Followup,Followup
• Report Date (Section B): 04/19/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/03/2024; 06/05/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/04/2024; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2012
• 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