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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; Tip
Event Date 07/10/2015
Event Type  Malfunction  
Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

 
Event Description

It was reported that the tip broke inside the patient bone; however, the tip was removed from the patient and there was no surgical intervention/harm to patient.

 
Manufacturer Narrative

The reported device was not received for investigation; therefore the reported failure cannot be confirmed. The complaint will be closed without a detailed investigation report and based on probable root cause. In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results. Probable root cause for the reported failure involving this device could have been caused by: design: -cable design is weak. -drill too dull or dulls quickly, inefficient flute design, requires excessive force to advance. -drill not in alignment with guide. -drill allowed to extend too far out of guide. Process: -drill manufactured out of specification. -drill guide manufactured out of specification. -affected heat zone from weld too large, cable weakened. Application: -excessive axial force on drill, -run drill in reverse, -reuse/resterilization of single-use device, or use of a single drill on multiple defects, -hard bone, -guide is translated and/or rotated during drilling; drill not in alignment with guide, -user does not use snap cap, drills too deep, -drill is started/stopped while in bone (technique guide instructs to run continuously during drilling). The product was not returned for investigation therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence.

 
Event Description

It was reported that the tip broke inside the patient bone; however, the tip was removed from the patient and there was no surgical intervention/harm to patient.

 
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Brand NameMICROFX OCD UNIVERSAL DRILL
Type of DeviceREAMER
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
kimberly lynch
5900 optical court
san jose , CA 95138
4087542000
MDR Report Key4974180
Report Number0002936485-2015-00710
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/10/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/05/2015
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 Number56886
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2015
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

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