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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 01/09/2014
Event Type  malfunction  
Event Description
It was reported that after drilling about 5 holes the next attempted resulted in no drill hole.The surgeon pulled the drill out and found that the tip had broken off in the patient.He was able to retrieve the tip using a tissue grasper.
 
Event Description
It was reported that after drilling about 5 holes the next attempted resulted in no drill hole.The surgeon pulled the drill out and found that the tip had broken off in the patient.He was able to retrieve the tip using a tissue grasper.
 
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Manufacturer Narrative
The product was returned for investigation.The reported failure mode was confirmed.The drill is broken at the proximal end of the cable where the cable meets the rigid shaft of the drill.The cable appears to be unraveling near the drill tip and the drill tip shows wear along the cutting edges.Based on the event description and additional information provided, hard bone as well as user technique leading to skiving are considered the primary root causes.In sum, 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 Key3602677
MDR Text Key4066184
Report Number0002936485-2014-00052
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 01/09/2014
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 Number43999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/09/2014
Initial Date FDA Received01/31/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/12/2014
Was Device Evaluated by Manufacturer? Yes
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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