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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE MICROFX OCD UNIVERSAL DRILL; REAMER
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STRYKER ENDOSCOPY-SAN JOSE MICROFX OCD UNIVERSAL DRILL; REAMER Back to Search Results
Catalog Number 234-200-200
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2014
Event Type  malfunction  
Event Description
It was reported that while drilling to a depth of 6mm, the surgeon stopped the drill and then started the drill again.As the drill was rotating the surgeon tried to pull the drill out when the tip of the drill bit snapped off in the bone.The tip of the drill was retrieved from the bone and there were no further complications.
 
Event Description
It was reported that while drilling to a depth of 6mm, the surgeon stopped the drill and then started the drill again.As the drill was rotating the surgeon tried to pull the drill out when the tip of the drill bit snapped off in the bone.The tip of the drill was retrieved from the bone and there were no further complications.
 
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The device was visually inspected and it was confirmed that the distal metal drill tip of the device had broken away at the distal end of the flexible coil.Some of the metal coil pieces were worn and bent, which is indicative of skiving.The most likely explanation for the failure is that the guide was not held flush against the patient bone causing the drill to skive and get damaged by the guide teeth.The damaged drill would not have the necessary mechanical properties to perform the microfx surgery and thus, break.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
 
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Brand Name
MICROFX OCD UNIVERSAL DRILL
Type of Device
REAMER
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
thomas shafer
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key3817362
MDR Text Key4501548
Report Number0002936485-2014-00345
Device Sequence Number1
Product Code HTO
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 Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/24/2014
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
Device Operator Health Professional
Device Catalogue Number234-200-200
Device Lot Number48977
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/24/2014
Initial Date FDA Received05/19/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/27/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age44 YR
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