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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HEADLESS PIN DRIVER; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH HEADLESS PIN DRIVER; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-4-809
Device Problems Mechanical Problem (1384); Mechanics Altered (2984)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/09/2015
Event Type  malfunction  
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
Event Description
The instrument is suppose to push driving pins into the bone and suppose to support to remove them from the bone.Surgeon reported that the part doesn't have a locking mechanism to lock the pin.It demand hard loading which is difficult when the hands/pins are bloody.Pushing the pin against the bone, before operating the power tools is a problem as enough that the surgeon want do it 1 of 10 times, and the spring/pin head is ruined.While pushing the pins deep, it impossible to pull them using the item as you can push it against the bone.
 
Manufacturer Narrative
Reported event: an event regarding an assembly issue involving a headless pin driver was reported.The event was confirmed by the visual and functional inspections.A visual and functional inspection revealed that the ball seal spring (part no.9000-8-423) inside the headless pin driver was found to be deformed.This obstructed the opening of the driver that accepts the pin.Therefore the pin could not be inserted far enough to fully engage the square drive portion of the driver.Device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events reported for this manufacturing lot.Conclusion: the investigation determined the likely root cause of the event to be user misuse.The damage is consistent with a previous operator not fully engaging the driver onto the square end of the pin before applying torque to the driver.The spinning driver and ball seal spring could then directly engage square edges of the square end of the pin permanently deforming the ball seal spring.It was also concluded that there is no indication the event is related to a manufacturing issue.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.
 
Event Description
The instrument is suppose to push driving pins into the bone and suppose to support to remove them from the bone.Surgeon reported that the part doesn't have a locking mechanism to lock the pin.It demand hard loading which is difficult when the hands/pins are bloody.Pushing the pin against the bone, before operating the power tools is a problem as enough that the surgeon want do it 1 of 10 times, and the spring/pin head is ruined.While pushing the pins deep, it impossible to pull them using the item as you can push it against the bone.
 
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Brand Name
HEADLESS PIN DRIVER
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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
jadwiga degrado
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5141347
MDR Text Key28319245
Report Number0002249697-2015-03293
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6541-4-809
Device Lot Number19500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received12/23/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2015
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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