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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X340MM X 130 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X340MM X 130 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3430-1340S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Exsanguination (1841); Perforation (2001)
Event Date 09/06/2020
Event Type  Death  
Manufacturer Narrative
Device was not returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition unknown.
 
Event Description
As reported: "i was made aware by another consultant of an event that occurred - where a gamma nail was implanted in the patient, however the tip-apex distance of the lag screw was wrong so the screw cut out and needed revision, patient started losing a large amount of blood and later was pronounced deceased in icu. The case and corresponding surgeon is now under investigation. ".
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X340MM X 130
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10871616
MDR Text Key217295377
Report Number0009610622-2020-00717
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3430-1340S
Device Catalogue Number34301340S
Device Lot NumberUNKNOWN
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 Received10/26/2020
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 Treatment Data
Date Received: 11/19/2020 Patient Sequence Number: 1
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