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

Catalog Number CRANI-A

Device Problems Break (1069); Detachment Of Device Component (1104); Structural Problem (2506); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Gtin is unavailable as the product was made prior to compliance date; (b)(4).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.(b)(4) evaluated the device and the reported condition was confirmed.However, the assignable root cause could not be determined.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that during service and evaluation, it was observed that the bearings on the craniotome device were damaged.It was further determined that the ball bearings fell apart, the balls and ball cage were not available and the crane bracket edges were sharp.The device also failed the following pre-tests: cutter insertion and visual assessment.It was reported in the service order that the rolling bearing was broken.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.All available information has been disclosed.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 POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 5896565
• MDR Text Key: 53549554
• Report Number: 1045834-2016-12507
• Device Sequence Number: 1
• Product Code: HBC
• 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: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 07/21/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1