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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE MICROFX OCD UNIVERSAL DRILL; BIT, DRILL

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STRYKER ENDOSCOPY-SAN JOSE MICROFX OCD UNIVERSAL DRILL; BIT, DRILL Back to Search Results
Catalog Number 234-200-200
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2022
Event Type  malfunction  
Event Description
It was reported that the tip of the drill broke during the procedure.The tip was retrieved.
 
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
 
Event Description
It was reported that the tip of the drill broke during the procedure.The tip was retrieved.
 
Manufacturer Narrative
The device manufacturer date is not known.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: snapped off.Probable root cause: design.Stackup issue between drill/guide.Coil too stiff.Process.Drill manufactured out of specification.Drill guide/snap caps manufactured out of specification.Application: excessive force on drill guide bends shaft.Not running drill when removing bit from bone." the reported failure mode will be monitored for future reoccurrence.H3 other text: 81.
 
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Brand Name
MICROFX OCD UNIVERSAL DRILL
Type of Device
BIT, DRILL
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
andrea zenere
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key15485516
MDR Text Key300579007
Report Number0002936485-2022-00529
Device Sequence Number1
Product Code HTW
UDI-Device Identifier37613327004091
UDI-Public37613327004091
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
Report Date 11/09/2022
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 NumberW79714/1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/29/2022
Initial Date FDA Received09/26/2022
Supplement Dates Manufacturer Received08/29/2022
Supplement Dates FDA Received11/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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