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

Catalog Number CRANI-L

Device Problem Degraded (1153)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported from japan that during service and evaluation, it was determined that the craniotome device had a bent/damaged neuro tip, was difficult to assemble/disassemble, worn bearing, unexpected noise, vibration, color band chipping/fading, locking mechanism stiff/stuck and the cutter could not be inserted.It was further determined that the device failed pretest for visual, color band, lock operation, cutter and vibration.It was noted in the service order that the device yellow marking was damaged.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2022.All available information has been disclosed.If additional information should become available, an additional report will be submitted accordingly.

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.Additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component wear.Udi:(b)(4).

• Brand Name: 7.5CM LARGE CRANIOTOME ATTCH
• Type of Device: 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: 15968502
• MDR Text Key: 306623025
• Report Number: 1045834-2022-01702
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 84538400175
• UDI-Public: 84538400175
• Combination Product (y/n): N
• PMA/PMN Number: K011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRANI-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1