MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BATTERY REAMER/DRILL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.605

Device Problems Melted (1385); Overheating of Device (1437); Loss of Power (1475)

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

Event Date 10/22/2014

Event Type  malfunction  

Event Description

This is report 1 of 2 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the battery reamer drill device overheated and stopped functioning.According to the reporter, the device was then switched off and on again.However, the device was still not functioning.The reporter indicated that the battery inside the casing was checked and it was found that part of the battery housing was melted.There were no delays to the planned surgical procedure as a spare device was available for use.There was patient involvement.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 control unit of the device was not functioning.It was further determined that the electronic control unit had no function and the motor pulled too many amperes.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available; a supplemental medwatch report will be sent accordingly.

• Brand Name: BATTERY REAMER/DRILL
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• 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: 4240633
• MDR Text Key: 5066558
• Report Number: 3009450871-2014-10572
• 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,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.605
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1