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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 36MM +5MM V40 TRIAL HEAD; INSTRUMENT
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STRYKER ORTHOPAEDICS-MAHWAH 36MM +5MM V40 TRIAL HEAD; INSTRUMENT Back to Search Results
Catalog Number 6264-8-236R
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2014
Event Type  malfunction  
Event Description
When the doctor was done trialing the head for final sizing the red ring broke as he was pulling the head trial off the stem.No action was needed because this happened as the doctor was removing the trial.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
An event regarding a damaged o-ring involving a partnership trial head was reported.The event was confirmed.Method & results:-device evaluation and results: visual inspection confirmed the reported event.The damage to the o-ring appears to have been caused by a sharp instrument used to extract the device during the surgical procedure.-medical records received and evaluation: not performed as medical records were not provided for evaluation.-device history review: review of device history records indicates the lot was manufactured and accepted into final stock free of discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded that the reported damage to the o-ring appears to have been caused by a sharp instrument used to extract the device during the surgical procedure.
 
Event Description
When the doctor was done trialing the head for final sizing the red ring broke as he was pulling the head trial off the stem.No action was needed because this happened as the doctor was removing the trial.
 
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Brand Name
36MM +5MM V40 TRIAL HEAD
Type of Device
INSTRUMENT
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
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4848866
MDR Text Key5935771
Report Number0002249697-2015-01954
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6264-8-236R
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/03/2014
Initial Date FDA Received06/16/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/05/2015
Was Device Evaluated by Manufacturer? No
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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