DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
|
Back to Search Results |
|
Catalog Number 532.103 |
Device Problems
Device Operates Differently Than Expected (2913); Electrical Shorting (2926)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/01/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).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.
|
|
Event Description
|
This is report 7 of 11 for the same event: it was reported that during an unspecified surgical procedure, it was observed that two small battery drive devices would not work when used together with nine battery devices.According to the report, the battery devices appeared to short out when used with the small battery drive devices.It was further reported that the battery devices were dead when tested after the surgery, although the universal charger device showed that they were fully charged.There were no delays to the surgical procedure as spare devices were available to complete the surgery successfully.There was 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.
|
|
Manufacturer Narrative
|
The actual device was returned for evaluation.Reliability engineering evaluated the device.The external features of the device were visually inspected and it was determined that there was no evidence of abuse or manufacture issues.The device was tested and it was confirmed that the device was damaged.It was determined that the device had a blown fuse.Therefore, the reported condition was confirmed.It was determined that the root cause of the battery failure was due to excessive current that caused the battery to blow the fuse, suggesting that the battery had been connected to a device that had a short circuit.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|