MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS UNIVERSAL BATTERY CHARGE II; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.204_DL

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Overheating of Device (1437); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the universal battery charger device made a popping noise and smelled like something was burnt inside.The event was reported to have occurred at the office.There was no patient involvement reported.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.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the device presented a short circuit to the power supply line.It was determined that the power supply was not functioning and was defective.It was further determined that the device was damaged due to improper handling, most probably due to a fall.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due improper handling, which is user error/misuse/abuse.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNIVERSAL BATTERY CHARGE II
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6069464
• MDR Text Key: 59220248
• Report Number: 8030965-2016-15410
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.204_DL
• Device Lot Number: 000162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2009
• 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