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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP STD R 65MM; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP STD R 65MM; IMPLANT Back to Search Results
Catalog Number 64952040
Device Problems Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2015
Event Type  malfunction  
Manufacturer Narrative
The device was implanted into the patient and will not be returned, however, the packaging was returned to stryker for investigation.When completed, the evaluation summary will be submitted in a supplemental report.Packaging only.
 
Event Description
During a gmrs operation, the distal femoral implant box was damaged on the outside.When the first package was opened damage was noticed to the plastic container, the innermost packaging was not damaged so the inner package was opened outside the sterile field and the surgeon took the implant directly from the innermost packaging.
 
Manufacturer Narrative
An event regarding packaging damage involving a gmrs distal femoral component was reported.The event was confirmed.Method & results: device evaluation and results: the unit carton was returned without its shrink wrap opened.The unit carton is damaged with several compression marks and indentation lines evident throughout the package.The outer blister flange is cracked and broken off completely on one side.The inner blister lid was opened when returned.There is evidence of a good seal.The component within was used.The damage noted on the unit carton in particular indicates that the pack was mishandled and compressed to the extent that the flange on the outer blister broke.Medical records received and evaluation: not performed as the reported device was not implanted.Device history review: dhr review determined that the lot was manufactured and packed to specification.Complaint history review: there have been no similar events for the reported lot.Conclusions: visual inspection of the returned pack found indications that the pack was mishandled and compressed to the extent that the flange on the outer blister broke.No further investigation for this event is possible at this time.
 
Event Description
During a gmrs operation, the distal femoral implant box was damaged on the outside.When the first package was opened damage was noticed to the plastic container, the innermost packaging was not damaged so the inner package was opened outside the sterile field and the surgeon took the implant directly from the innermost packaging.
 
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Brand Name
GMRS DIST FEM COMP STD R 65MM
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK (MDR)
raheen business park
limerick 00000
EI   00000
Manufacturer Contact
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4943513
MDR Text Key23010697
Report Number0002249697-2015-02470
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K023087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other
Report Date 07/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2018
Device Catalogue Number64952040
Device Lot NumberEEAFK
Other Device ID NumberSTERILE LOT: PA107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/21/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/08/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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