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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HUMERAL NAIL, AP T2 HUMERUS Ø7X240 MM; IMPLANT
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STRYKER TRAUMA KIEL HUMERAL NAIL, AP T2 HUMERUS Ø7X240 MM; IMPLANT Back to Search Results
Catalog Number 18301724S
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2019
Event Type  malfunction  
Manufacturer Narrative
The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
It was reported that when physician tried to insert the device into the bone, he found a piece like a sponge in the screw hole of proximal side.The device was taken out from the bone and changed to another shorter one.The procedure was successfully with no adverse consequences or surgical delay.
 
Manufacturer Narrative
The reported event could not be confirmed, since no residues were found in the implant.The review of the dhr revealed no discrepancies, in particular in the packaging process.The device returned was documented as faultless prior to distribution.The reported event could not be reproduced as the packaging was received in opened condition.Thus, pollution in original condition could not be verified.It could not be excluded that the pollution potentially occurred at the user site.Based on the above observations the root cause could not be determined.No discrepancies were detected during risk analysis review.No non-conformity was identified.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
 
Event Description
It was reported that when physician tried to insert the device into the bone, he found a piece like a sponge in the screw hole of proximal side.The device was taken out from the bone and changed to another shorter one.The procedure was successfully with no adverse consequences or surgical delay.
 
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Brand Name
HUMERAL NAIL, AP T2 HUMERUS Ø7X240 MM
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key8716500
MDR Text Key149201965
Report Number0009610622-2019-00500
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2023
Device Catalogue Number18301724S
Device Lot NumberK0C8B92
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2019
Date Manufacturer Received06/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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