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

Model 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	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from japan that parts of the craniotome device were dropping off.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned 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 2023.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.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.The actual device was returned for evaluation.The craniotome device was evaluated and the reported condition that parts of the device were dropping off was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device had component damage.It was further determined that the device failed pretest for visual assessment.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi: (b)(4).

• 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 ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 16545871
• Report Number: 1045834-2023-00382
• Device Sequence Number: 15083238
• Product Code: ERL
• UDI-Device Identifier: 00845384001751
• UDI-Public: 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Device Catalogue Number: CRANI-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2020
• 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