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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HUMERAL NAIL, AP T2 HUMERUS 8X240 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL HUMERAL NAIL, AP T2 HUMERUS 8X240 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18301824S
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2020
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device remains implanted in patient.
 
Event Description
It was reported: the protruding part of the connection between the proximal end of the t2 nail and the target device was damaged intraoperatively. At the doctor's discretion, the nail was inserted as it was without replacement.
 
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Brand NameHUMERAL NAIL, AP T2 HUMERUS 8X240 MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10062323
MDR Text Key191318007
Report Number0009610622-2020-00247
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number18301824S
Device Lot NumberK040A35
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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