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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 4.0MM DRILL GUIDE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH 4.0MM DRILL GUIDE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 2107-4017
Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Mechanical Jam (2983); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2015
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
Doctor had already inserted the titanium cup and wanted to place a couple of screws.As he turned the drill on with the 25mm x 4mm trident drill in the 4mm drill guide the drill 'jammed' or locked up in the guide.It took a few minutes to try and dislodge the drill from the guide but it wouldn't come out.
 
Manufacturer Narrative
Device was not returned for evaluation.An event regarding a seized trident guide was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned for inspection.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no similar previous reported events.Conclusions: the exact cause of the event could not be determined because the device was not returned for inspection.No further investigation for this event is possible at this time.If the devices become available, this investigation will be reopened.
 
Event Description
Doctor had already inserted the tritanium cup and wanted to place a couple of screws.As he turned the drill on with the 25mm x 4mm trident drill in the 4mm drill guide the drill 'jammed' or locked up in the guide.It took a few minutes to try and dislodge the drill from the guide but it wouldn't come out.
 
Manufacturer Narrative
An event regarding a seized trident guide was reported.The event was confirmed.Method & results: device evaluation and results: visual confirmed the event as the drill bit was seized in the trident guide in one of the bushings.There are light scratches in various areas.Review of device with material analysis engineer indicated there is evidence of wear and multiple usage can lead to galling.There is likely debri degeneration in the bushing where the bit is stuck.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no similar previous reported events.Conclusions: visual confirmed the event of seizing.The drill bit was stuck in one of the bushings on the drill guide.The bit stuck inside the guide showed signs of deformation from use.There is evidence of wear and multiple usage can lead to galling.There is likely debri degeneration in the bushing where the bit is stuck.No further investigation for this event is possible at this time.If the devices become available, this investigation will be reopened.
 
Event Description
Doctor had already inserted the tritanium cup and wanted to place a couple of screws.As he turned the drill on with the 25mm x 4mm trident drill in the 4mm drill guide the drill 'jammed' or locked up in the guide.It took a few minutes to try and dislodge the drill from the guide but it wouldn't come out.
 
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Brand Name
4.0MM DRILL GUIDE
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5248516
MDR Text Key32148790
Report Number0002249697-2015-04019
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K151264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2107-4017
Device Lot NumberH7562
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/1997
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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