MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 11CM ANGLE ATTACHMENT, BLACK MAX; DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT

Catalog Number B-QD11

Device Problems Loose or Intermittent Connection (1371); Chemical Problem (2893); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2014

Event Type  malfunction  

Event Description

It was reported by (b)(6) that during reassembly of the motor device, it was observed that the attachment device loosened along the shaft and came apart completely.It was further reported that it appeared as if the seal had let go and was heavily soiled with "bioburden".The event did not occur during surgery.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device failed nose tube assembly.Therefore the reported condition was confirmed.The assignable root cause was determined to be due to loctite deterioration due to sterilization process/immersion which is misuse, abuse and/or error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 11CM ANGLE ATTACHMENT, BLACK MAX
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT
• 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: 4163825
• MDR Text Key: 4868801
• Report Number: 1045834-2014-13318
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK002903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-QD11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1