MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC UNIVERSAL BATTERY CHARGER II; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number	05.001.204
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products and therapy dates: power module device (b)(6) 2020).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.Udi ¿ (b)(4).
Event or Problem Description
It was reported from (b)(6) that prior to a surgical procedure for a lower leg bone shaft fracture, while in the central supply room, it was observed that the battery charger device produced a blue spark when the power module device was plugged into the charger device.It was reported that the charger device then generated white smoke and a burnt smell.It was reported that the staff waited for a while, but the device kept generating the white smoke.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.It was reported that the power module had been charged enough and could be used in the surgery without problems.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The manufacturing site name was documented as synthes produktions gmbh (waldenburg) in the initial report.This has been updated to oberdorf synthes produktions gmbh (oberdorf).Please note that the contact office name/address have been updated accordingly to reflect the corrected manufacturing facility.The date of manufacture (dom) was documented as december 13, 2011 in the initial medwatch report.The dom has been corrected to june 18, 2015.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the fuses of the battery charger device were blown, which indicates that there was a malfunction of the power supply.The device was disassembled and it was observed that the power supply printed board showed traces of burning.After checking the diode (d1) of the power supply, a broken conductor path could be found which indicates damage by dropping.Due to the drop event, the via of the diode [pos.D1] broke.Due to the broken via, a high current flowed back in the primary switching-net of the power supply, which caused damage to several parts in the power supply.The burned components and copper/epoxy caused the white smoke.A review of the device history was performed and non-conformances were detected related to the reported condition.It was determined that improper damage by dropping was the root cause of the failure.The assignable root cause was determined to be traced to user, which is user error.

• Brand Name: UNIVERSAL BATTERY CHARGER II
• Common Device Name: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9707763
• Report Number: 8030965-2020-00823
• Device Sequence Number: 3474921
• Product Code: MOQ
• UDI-Device Identifier: 07611819977846
• UDI-Public: 7611819977846
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05.001.204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 02/20/2020; 05/18/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 02/27/2020; 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1