MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 7.5CM LARGE CRANIOTOME ATTCH; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC)

Catalog Number	CRANI-L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
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.H11 additional narrative: d11: concomitant med products and therapy dates: medium attachment device, short craniotome attachment device and adult craniotome attachment device device, 8/15/2024 e1: the initial reporter's phone number was not provided.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
Report 3 of 4 for this event.It was reported from japan that the inner parts of the short attachment device, medium attachment device, adult craniotome attachment device and large craniotome attachment device came off.It was not reported if the devices were used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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.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.H11 additional narrative: correction: device availability: d9: the device availability date was incorrect in the initial report.The date has been updated from 8/16/2024 to 8/22/2018.Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition that inner parts came off.Was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device had a worn bearing, exhibited vibration, produced unexpected noise, was difficult to assemble/disassemble, craniotome neuro tip was bent/damaged.It was noted that the device had dural guard scratches and motor connection was snagging.It was further determined that the device failed pretest for verification: visual assessment, lock operation and verification: vibration.The assignable root cause was determined to be due to component failure from wear.

• Brand Name: 7.5CM LARGE CRANIOTOME ATTCH
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 20023444
• Report Number: 1045834-2024-00805
• Device Sequence Number: 12603711
• Product Code: ERL
• UDI-Device Identifier: 00845384001751
• UDI-Public: (01)00845384001751
• 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
• Report Date (Section B): 08/19/2024

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-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2017
• 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