|
Catalog Number 03.010.100 |
Device Problem
Vibration (1674)
|
Patient Problem
Patient Problem/Medical Problem (2688)
|
Event Date 12/09/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).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 Description
|
This is event 4 of 4 of the same event.It was reported from (b)(6) that during a diaphyseal spiral surgical procedure for a humeral diaphysis fracture, it was observed that while using the radiolucent drive device the drill bit devices started to wobble.According to the reporter, the drill bit devices then stopped moving while in use with the device.The reporter stated that the surgeon attempted to drill while holding the base tight as the surgeon believed there was a connection issue with the handpiece device.However, the surgeon noted that the junction of the drill bit device and quick coupling device did not work properly.The reporter stated that the surgeon then attempted to fix the drive tip with tape so that the drill bit device would not fall without success.The reporter stated that eventually the drill but device tip was hit with a hammer.Therefore, the surgeon opened the other side with his hand and inserted screw devices to continue the surgical procedure.The reporter further indicated that a compact air drive device was in use during the procedure.According to the reporter, the cutter device did not break during the surgical procedure.It was unknown if a spare device was available for use.There was patient involvement.There was a thirty minute delay to the surgical procedure which caused the patient to lose blood.The amount of blood loss was not available from the reporter.The reporter was not able to specify if/what medical intervention was performed or if there was prolonged hospitalization as a result of the event.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Manufacturer Narrative
|
(b)(4).During subsequent follow-up with the customer, it was reported that there was an additional cutter device involved in this event.Therefore, this is report 4 of 5 of the same event.The lot number was reported as unknown in the initial medwatch, the lot number is u168224.The manufacturer location was documented as (b)(6) in the initial report.The location has been updated to unknown.Correction: the reporter country was submitted as unknown in the initial medwatch.The reporter country is (b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Patient id/initials, age/date of birth and weight are unknown.Implant and explant dates: device is an instrument and is not implanted/explanted.Initial reporter address and phone number: (b)(6).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.
|
|
Manufacturer Narrative
|
Manufacturing date: device received, inspected and released in synthes (b)(4) on january 16, 2013.Manufacturing location: supplier ((b)(4)).Business group: trauma.Device part 03.010.100 is a batch number controlled product, therefore no service history record review is possible.No non-conformance reports were generated during incoming inspection.Review of the device history record (dhr) showed that there were no issues found that would contribute to this complaint condition.The conclusion of the dhr review is that the final products received and released met inspection requirements, certification test values, and acceptance criteria.A manufacturing evaluation was completed: the reported failure could not be confirmed.However, the drill bit has damages on the side edge and the tip due to normal wear.The damages have no influence on the described complaint.No root cause can be assigned as no failure was found.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.
|
|
Search Alerts/Recalls
|
|
|