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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® Ø13X320MM X 120° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø13X320MM X 120° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3420-3320S
Device Problems Break (1069); Fracture (1260)
Patient Problems Failure of Implant (1924); Implant Pain (4561)
Event Date 03/24/2022
Event Type  Injury  
Event Description
As reported: "six months after g3 long surgery, the nail lag screw hole and distal transverse stop screw broke off. Patient complains of pain and requests data on g3 fracture. ".
 
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device remains implanted in the patient.
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø13X320MM X 120°
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14165883
MDR Text Key289730312
Report Number0009610622-2022-00146
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
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 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3420-3320S
Device Catalogue Number34203320S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2022
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: 04/21/2022 Patient Sequence Number: 1
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