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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W&H DENTALWERK BÜRMOOS GMBH RIGHT ANGLED SCREWDRIVER; INSTRUMENT
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W&H DENTALWERK BÜRMOOS GMBH RIGHT ANGLED SCREWDRIVER; INSTRUMENT Back to Search Results
Catalog Number 6514-7-200
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2016
Event Type  malfunction  
Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
 
Event Description
It was reported by the company representative that the screwdriver would heat up when drilling into the bone and would stop operating.There were three drivers experiencing the same issue; the surgeon rotated between the three screwdrivers and was able to complete the surgery.No adverse consequences were reported.
 
Manufacturer Narrative
The reported event could not be confirmed by the legal manufacturer with regards to the function of the screwdriver itself.Because stryker is only the distributor of the returned screwdriver, the device was forwarded to the legal manufacturer w&h for evaluation.Within the incoming functional inspection performed by w&h it was determined that the rotation function is slightly affected and during turning with the turning attachment a low resistance is noticeable which led to a deterioration of the smooth running of the screwdriver.After disassembly, the components of the screwdriver shows impurities which points to the fact that the device was not appropriately cleaned and lubricated.The appropriate cleaning, disinfection, sterilization and maintenance with service oil is described in the ifu provided by the legal manufacturer w&h.After cleaning and lubrication with the service oil of the screwdriver components the screwdriver ran flawlessly.The reported event that the core was being used at roughly 50.000 rpms did not meet the specifications and was therefore classified as user related issue.A further test with the max.Specified revolution speed of 10.000 rpms was performed by w&h.During operation with 10.000 rpms no noticeable heating of the screwdriver could be detected.Only a very slight running noise and vibration are existing but did not influence a flawlessly operation of the screwdriver.The final result of the investigation performed by w&h revealed that the screwdriver is fully functional and no defects could be detected.According to this, the screwdriver was classified as conform to specification.Therefore no measures were deemed to be necessary by the legal manufacturer for the screwdriver at this time.The issue of the involved power unit ¿ core system (stryker product) ¿ related to the affected drive of the screwdriver (w&h product) is being addressed by stryker in an ongoing capa.
 
Event Description
It was reported by the company representative that the screwdriver would heat up when drilling into the bone and would stop operating.There were three drivers experiencing the same issue; the surgeon rotated between the three screwdrivers and was able to complete the surgery.No adverse consequences were reported.
 
Manufacturer Narrative
The event details have been updated.
 
Event Description
It was previously reported on the initial mdr that the screwdriver would heat up when drilling into the bone and would stop operating.There were three drivers experiencing the same issue; the surgeon rotated between the three screwdrivers and was able to complete the surgery.No adverse consequences were reported.However, based on a follow up conversation with the company representative, it was noticed that not all of the initial information was correct.While the three drivers were not functioning properly, he is unsure how the description ¿heated up¿ was inserted in the event description, as he confirmed that they were not at all hot, and that they only jammed.The core was being used at roughly 50,000 rpms at the time that they stopped working.
 
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Brand Name
RIGHT ANGLED SCREWDRIVER
Type of Device
INSTRUMENT
Manufacturer (Section D)
W&H DENTALWERK BÜRMOOS GMBH
ignaz-glaser-strasse 53
bürmoos 05111
Manufacturer (Section G)
W&H DENTALWERK BÜRMOOS GMBH
ignaz-glaser-strasse 53
bürmoos 05111
Manufacturer Contact
kelli dykstra
boetzingerstr. 41
freiburg D-791-11
76145120
MDR Report Key6105933
MDR Text Key60552419
Report Number0008010177-2016-00273
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6514-7-200
Device Lot Number02137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received10/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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