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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, LEFT GAMMA3® Ø11X360MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 35251360S
Device Problems Loose or Intermittent Connection (1371); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/27/2019
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.
 
Event Description
It was reported: "once doctor had lag screw in correct position on the first nail, he put in the set screw but it did not engage into the proximal part of nail. It spun loosely and would not advance further distally or back out to try and re-position. The same exact outcome happened on the second nail. The set screw entered the nail and got stuck. Doctor tried a couple different set screwdrivers to try and back it out. Both nails resulted with stuck set screws that did not engage into the lag screws. Delay in surgery: 20 minutes. " procedure was completed successfully. The doctor concluded to leave both of the nails in. No additional surgery is planned. No adverse consequences reported.
 
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Brand NameLONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM X 125°
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9216243
MDR Text Key169022845
Report Number0009610622-2019-00872
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07613252274285
UDI-Public07613252274285
Combination Product (y/n)N
Reporter Country CodeUS
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 10/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number35251360S
Device Lot NumberK0F0A60
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 Received09/27/2019
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

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