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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X420MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X420MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 33250420S
Device Problem Crack (1135)
Patient Problems Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)
Event Date 07/22/2018
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
 
Event Description
The customer reported that a gamma nail which had been implanted on (b)(6) 2018 was revised on (b)(6) 2018. The surgeon reported a poor reduction due to the fracture pattern and also medial bone loss in the lesser trochanter. The patient was revised to a proximal femoral plate. Update: the customer reported that the patient turned and heard a crack. She did not fall. Patient presented to clinic. Patient had non-union prior to this reported event. Revision surgery completed "usccessfully. ".
 
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Brand NameLONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X420MM 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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7803316
MDR Text Key117829763
Report Number0009610622-2018-01028
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
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,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number33250420S
Device Lot NumberK099C78
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2017
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: 08/21/2018 Patient Sequence Number: 1
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