MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 8CM ANGLE ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number QD8

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during an unspecified pediatric surgical procedure it was observed that the angle attachment device had a dirty oil substance leaking out of the distal end.The reporter stated that the surgical site was irrigated and then frasier suctioned.It was reported that there was a fifteen minute delay in the procedure due to the event and an unspecified spare device was available for use.The procedure was successfully completed.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was observed that the nose tube bearings, spacers and locking mechanism were corroded from normal use over time.The assignable root cause was due to worn out beargins from normal use over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

Correction: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was observed that there was a cutter stuck inside of it thus not being able to perform a complete pretest.It was further noted that the nose tube bearings, spacers and locking mechanism were corroded.The assignable root cause was due to worn out bearings from normal use over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: 8CM ANGLE ATTACHMENT
• Type of Device: MOTOR, DRILL, ELECTRIC - 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: 5383825
• MDR Text Key: 36963932
• Report Number: 1045834-2016-10193
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: QD8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2008
• 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