MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC UNIVERSAL BATTERY CHARGER - 4 BAYS; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number	530.601
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter's phone number: (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.
Event or Problem Description
It was reported from (b)(6) that the universal battery charger device overheated.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.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
Manufacturer location: upon complaint review, it was determined that the manufacturer location was inadvertently documented as (b)(4) in the initial report.The location has been updated to (b)(4).Manufacture site name/address has been updated accordingly to reflect the corrected manufacturing facility.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: UNIVERSAL BATTERY CHARGER - 4 BAYS
• Common Device Name: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7088205
• Report Number: 8030965-2017-50355
• Device Sequence Number: 1450196
• Product Code: MOQ
• UDI-Device Identifier: 07611819977846
• UDI-Public: (01)07611819977846(11)061010
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 530.601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1