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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 31251180S
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Death (1802)
Event Date 04/26/2008
Event Type  Injury  
Manufacturer Narrative
The reported event that trochanteric nail kit, ti gamma3® ø11x180mm x 125° was alleged revision could not be confirmed since the device was not returned for evaluation and no other evidences were provided. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. This complaint has been reported during a literature review performed by the post market surveillance group. No product identification is possible and no additional information will be requested to the customer as this serves for trending purpose. A review of the labeling did not indicate any abnormalities. If any further information is provided, the investigation report will be updated. Device disposition is unknown.
 
Event Description
The manufacturer became aware of adverse events from the (b)(4) hip fracture register. The title of this report is ¿gamma 3 in the (b)(4) hip fracture register¿ which is associated with the gamma3 locking nail system, within that report, post-operative complications/ adverse events were reported, which occurred between 1-jan-2005 and 31-dec-2016. A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 290 complaints were initiated for the revision surgeries retrospectively for different adverse events mentioned in the report. This product inquiry addresses revision surgery due to malunion. Two hundred and seventy-one out of 290 cases. It was also indicated that patient died within 60 days of revision surgery however the cause and date of death will not be disclosed.
 
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Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM 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 Key7743648
MDR Text Key115896066
Report Number0009610622-2018-00451
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 08/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number31251180S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2018
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: 08/02/2018 Patient Sequence Number: 1
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