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

Model Number CRANI-A-G1

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the craniotome device foot plate was bent and the laser etching was worn.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 this event was unknown but was noted to have occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Quality engineering evaluated the device and determined that the neuro-tip foot was bent and the laser etching was worn and hard to read.The neuro-tip foot bent was due to excessive lateral force being placed on the device which caused it to bend, damage caused by user error.The worn out laser etching was due to normal wear over time.Therefore, the reported condition was confirmed.During review of the device manufacturing records for this device it was found that there were no anomalies that occurred during the manufacturing or processing of the device that would have been expected to cause or contribute to the reported event.The assignable root cause was determined to be due to user error/misuse/abuse and wear from normal use and servicing.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: ADULT CRANIOTOME
• Type of Device: MOTOR, DRILL, ELECTRIC - CRANIOTOME
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6103142063
• MDR Report Key: 8171230
• MDR Text Key: 130632787
• Report Number: 1045834-2018-52445
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 00845384016410
• UDI-Public: (01)00845384016410(11)141212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2018

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
• Device Operator: Health Professional
• Device Model Number: CRANI-A-G1
• Device Catalogue Number: CRANI-A-G1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 01/03/2019
• Supplement Dates FDA Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1