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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ADJUSTMENT BLOCK - STANDARD; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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STRYKER ORTHOPAEDICS-MAHWAH ADJUSTMENT BLOCK - STANDARD; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-1-600
Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976); Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/11/2017
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
During a tka, after pinning the guide for distal femur cut as standard for an 8mm resection, the cut was "basically air balling" (rep defined: when the surgeon put the saw through the guide and capture, the saw was not hitting any bone, instead of resecting 8mm of bone off the distal femur).The case was completed successfully.
 
Manufacturer Narrative
An event regarding annoyance (airballing) involving a triathlon other instrument was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual inspection showed the device to have scratching associated with normal use.Some damage was noted on the locking shaft assembly, consistent with contact with additional instrumentation.Examination of returned device by a material analyst engineer indicated: "in-service use damage observed." medical records received and evaluation: there is no indication that patient factors contributed to the reported event.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.There have been no other event for the lot referenced.Conclusions: it was reported that during a tka, after pinning the guide for distal femur cut as standard for an 8mm resection, the cut was airballing.A visual inspection showed the device to have scratching associated with normal use.Some damage was noted on the locking shaft assembly.Examination of returned device by a material analyst engineer indicated: "in-service use damage observed." therefore the event of 'airballing' was not confirmed.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
 
Event Description
During a tka, after pinning the guide for distal femur cut as standard for an 8mm resection, the cut was "basically air balling" (rep defined: when the surgeon put the saw through the guide and capture, the saw was not hitting any bone, instead of resecting 8mm of bone off the distal femur).The case was completed successfully.
 
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Brand Name
ADJUSTMENT BLOCK - STANDARD
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
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7010415
MDR Text Key92519160
Report Number0002249697-2017-03239
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123486
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
Report Date 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6541-1-600
Device Lot NumberP7V39
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2013
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;
Patient Age57 YR
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