MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BATT-HANDPIECE MOD F/TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 05.001.201

Device Problems Loss of Power (1475); Device Inoperable (1663)

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

Event Date 12/12/2014

Event Type  malfunction  

Event Description

It was reported by (b)(6) that the battery handpiece device was not working.It was further reported that the device had no power.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 serial number was unknown.Therefore, the manufacturing location and date of manufacture were unknown.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

During subsequent follow-up with the customer, additional information was obtained.Please see updated information below: this is report 1 of 2 of the same event.It was reported by (b)(6) that before surgery, it was observed the battery handpiece device did not work.It was further reported that there was no power being emitted from the device.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was no patient involvement.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.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the gear seized, jammed and was heavy moving.It was further observed that the power transferring mechanics appeared to be blocked.After disassembling the device, it was observed that there was dried blood residue mainly in the ball bearings.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper repair.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BATT-HANDPIECE MOD F/TRS
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• 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: 4367837
• MDR Text Key: 20017928
• Report Number: 2520274-2014-15581
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2015
• 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