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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HUMERAL NAIL T2 HUMERUS 8X240 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL HUMERAL NAIL T2 HUMERUS 8X240 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1830-0824S
Device Problem Fracture (1260)
Patient Problem Injury (2348)
Event Date 07/13/2020
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
 
Event Description
As reported: due to a fall, the implanted nail was broken.
 
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Brand Name
HUMERAL NAIL T2 HUMERUS 8X240 MM
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE  D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE   D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10380119
MDR Text Key202874236
Report Number0009610622-2020-00443
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540201478
UDI-Public04546540201478
Combination Product (y/n)N
Reporter Country CodeJP
PMA/PMN Number
K032523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1830-0824S
Device Catalogue Number18300824S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Required Intervention;
Patient Age80 YR
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