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

Model Number	CRANI-L-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	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: device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, an evaluation was performed and it was determined that the reported condition of the craniotome leg being drilled into, identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to user, which is user error.Udi: (b)(4).
Event or Problem Description
It was reported that during service and repair pre-testing, it was discovered that the crani-tip of the craniotome device was damaged.It was observed that the craniotome leg was drilled into.It was further determined that the device failed pretest for visual assessment.There was no patient involvement.There were no injuries or medical intervention associated with this event.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 14208166
• Report Number: 1045834-2022-00500
• Device Sequence Number: 1803293
• Product Code: HBC
• UDI-Device Identifier: 00845384016427
• UDI-Public: 00845384016427
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2022

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: 03/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2014
• 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