MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BATTERY CASING F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	530.680
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing site name and address were unknown.The serial number was unknown.Therefore, device manufacture date is unknown.Concomitant medical products: battery casing device, battery reamer/drill device, battery device.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
This is report 1 of 2 for the same event: it was reported from (b)(6) that during a total joint replacement surgical procedure, it was discovered that while the surgeon was using the battery reamer/drill device, smoke started coming from the battery casing device of the drill device.It was reported that another battery device was used; however, the same issue occurred.There were no delays to the surgical procedure as spare devices were available to complete the surgery.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown, however it was reported that the event occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
Upon subsequent follow-up with the customer, additional information was received.The reporter clarified that the smoke was coming from inside the battery casing device.It was further reported that the plastic around the battery contacts melted.According to the reporter, the end users did not have any problems with the original battery nor with the spare battery.And both battery devices were still being used.
Additional Manufacturer Narrative
Additional information: the device serial number was unknown in the initial report; therefore, the device manufacture date was also unknown.The serial number was identified as (b)(4).The device manufacture date was updated to 1/6/2009.Therefore, udi has been updated accordingly.Manufacturer location was documented as unknown in the initial report.The location has been updated to (b)(4) contact office name/address has been updated accordingly to reflect the corrected manufacturing facility.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 actual device was returned for evaluation.The device was evaluated and the reported condition was confirmed.It was determined that the device was leaky.It was determined that the seal was wornout, the electrical contact was damaged and the housing was leaking.It was observed that the contacts were defective.The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report 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.D10, h3, h6: 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.

• Brand Name: BATTERY CASING F/BPL
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7272910
• Report Number: 8030965-2018-51084
• Device Sequence Number: 122861
• Product Code: GEY
• UDI-Device Identifier: 07611819137172
• UDI-Public: (01)07611819137172
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 01/25/2018

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: 530.680
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 02/21/2018; 04/11/2018; 06/06/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 02/22/2018; 04/16/2018; 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1