MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS MINI AIR DRILL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 512.100

Device Problems Partial Blockage (1065); Material Separation (1562); Difficult or Delayed Activation (2577); Connection Problem (2900); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported from (b)(6) that the mini air drill device fell apart.According to the report, the user put the device back together.The reporter stated that the coupling part of the device was not functioning properly as it was difficult to attach and insert attachment devices on the device.During in-house engineering evaluation, it was observed that the device had seized, jammed, and was heavy moving and the motor was blocked.It was further observed that the starter lever was loose.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any 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.

Manufacturer Narrative

(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.An assessment was performed on the device and it was observed that the device had seized, was jammed, and was heavy moving.It was further noted that the motor was blocked and the starter lever was loose.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: MINI AIR DRILL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; ni
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; ni; ni
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4897148
• MDR Text Key: 6829619
• Report Number: 2520274-2015-14735
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PEXEMPT
• 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
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 512.100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2015
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTACHMENT DEVICES