MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS LID F/BATT-HANDPIECE NO. 05.001.201 F/TR; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.227

Device Problems Partial Blockage (1065); Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and identified no failure.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

This is report 2 of 2 for the same event.It was reported by (b)(6) that during service and evaluation, it was observed that the handpiece device gears are blocked and was found to be heating due to debris inside.It was further noted that the device failed pre-repair diagnostic tests for response of on/off trigger, function of all modes, falling out protection (steal ring), free moving, and for leakage.It was noted in the service order "drill not working previously drill hand piece and lid get heat immediately when in use for drilling/reaming".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: LID F/BATT-HANDPIECE NO. 05.001.201 F/TR
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5500682
• MDR Text Key: 40634071
• Report Number: 8030965-2016-11590
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PEXEMPT
• 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: 02/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2011
• 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