MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 6.5CM ADULT CRANI ATTACHMT; MOTOR, DRILL, ELECTRIC - CRANIOTOME

Catalog Number CRANI-A

Device Problems Vibration (1674); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device manufacture date: the device manufacture date is unavailable.Service review: a review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the neuro tip of the craniotome device was damaged, the bearings were damaged, and the identification was unreadable.It was noted that the crani temple was bent, and the warning triangle was missing.It was further determined that the device failed pretest for visual assessment, and vibration.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 not reported, however, it was reported that the event occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.It was documented in the initial medwatch report that a review of the service history record indicated that the device had not been serviced for a service condition that is relevant to the current reported condition.Upon further investigation it was noted that a review of the service history record indicates that the device had been returned previously for the same malfunction.It was documented in the initial medwatch report that the date of manufacture (dom) was unknown.The dom (march 23, 2011) has been updated to reflect the date the device was manufactured.The unique identifier (udi) has been updated accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 6.5CM ADULT CRANI ATTACHMT
• 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: 8175652
• MDR Text Key: 130794987
• Report Number: 1045834-2018-52460
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 845384001720
• UDI-Public: (01)845384001720
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

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 Catalogue Number: CRANI-A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 12/26/2018
• Supplement Dates FDA Received: 01/07/2019
• Date Device Manufactured: 03/23/2011
• 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