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

Catalog Number	532.132
Medical Device Problem Codes	Fire (1245); Appropriate Device Problem Term/Code Not Available (3191); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Concomitant med products and therapy dates: small battery drive device, (b)(6) 2021.Device history review: a review of the device history record was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.As of this date, the device has not been returned for evaluation; therefore the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
Event or Problem Description
This is report 2 of 2 of the event.It was reported from france that during pre-surgery, while the surgeon was preparing the devices for the procedure, it was discovered that the small battery drive device stopped working while in use with the battery casing device.According to the reporter, when the surgeon put the battery device inside the motor device, it produced sparks and a lot of smoke and was smelling of burn.After that, the motor did not turn on anymore.Another battery device was tried, however the device still did not work and it was smelling of burn.It was noted that biomed did not know if the problem was coming from the small battery drive device or the battery casing device so both devices will be returned.However, additional information was received indicating that the battery casing device would not be returned for further investigation.It was reported that there were no delays to the surgical procedure as a spare device was available for use.There was no patient involvement reported.There were no reports of 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.

• Brand Name: SMALL BATTERY DRIVE CASING F/ 14.4 VOLT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12495442
• Report Number: 8030965-2021-07684
• Device Sequence Number: 19682575
• Product Code: HWE
• UDI-Device Identifier: 07611819418301
• UDI-Public: 07611819418301
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2021

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: 532.132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1