MAUDE Adverse Event Report: SYNTHES GMBH SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	532.103
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This is report 2 of 3 for the same event.It was reported that during an unspecified surgical procedure, it was observed that the colibri handpiece device while being used with a battery device and a casing device, caught fire.It was not reported if there were any delays in the surgical procedure.It was reported that a spare device was available for use and that there were no patient consequences.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.D4, h4: the device serial/lot number and date of manufacture are unknown at this time.Udi:(b)(4).
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 this medwatch, a supplemental medwatch report will be filed as appropriate.H11 additional narrative: b5: during a subsequent follow-up with the reporter, additional information was obtained.The reporter confirmed that smoke was coming from the motor and that only the colibri handpiece device caught fire.There was a slight delay in the surgical procedure to obtain another device.It was further reported that the user was not harmed.H6: the health effect - impact code has been updated accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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.Based upon the information reported in the previous report #8030965-2024-07243 this device is no longer reportable for this event.

• Brand Name: SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 19497193
• Report Number: 8030965-2024-07244
• Device Sequence Number: 6734604
• Product Code: HWE
• UDI-Device Identifier: 10886982241177
• UDI-Public: 10886982241177
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2024

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: 532.103
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 07/12/2024; 07/24/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/16/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown