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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 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 31301180S
Device Problem Cut In Material (2454)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 01/19/2015
Event Type  Injury  
Event Description
Patient sustained a right hip fracture on (b)(6) 2014 as a result of a fall.Gamma 3 nail was implanted on (b)(6) 2014.Increased pain in the right hip, x-ray showed cut out of lag screw.Patient hospitalized on (b)(6) 2015.Subject had revision surgery on (b)(6) 2015.Reason given for revision was malunion.
 
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Product disposition unknown.
 
Manufacturer Narrative
Investigation summary: the nail kit (containing the set screw) was classified as primary product during investigation.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail kit was documented as faultless prior to distribution.Technical investigation: an investigation of the implants them self was not possible because the nail kit was not available.The provided x-rays show that the laterally end of the lag screw is almost completely placed within the nail hole.This indicates that the set screw was not correctly placed: the set screw was not inserted deeply enough to reach one of the lag screw flutes.The insertion into a flute prevents the lag screw against rotation and limited the lag screw¿s movement towards medial and lateral.The correct set screw insertion is a critical surgery step and is described in detail in the operative technique.Clinical investigation: all provided information and the x-rays were evaluated by a medical expert: ¿the implant failure has been caused by a serious surgical error as the gamma set screw has been incorrectly (not deep enough) positioned.Under these circumstances it is quite lucky that the screw has not penetrated into the smaller pelvis which would have born a significant risk of fatal lesion of the pelvic vessels.¿ it is also reported that the patient is diabetic and a mal-union was detected.Mal-unions and diabetes can lead to implant failures and are listed as adverse effects in the ifu.Because no manufacturer related issues were found the case is attributed to a deviation from the surgical technique (user error), maybe contributed by patient conditions.No discrepancies were detected during risk analysis review.No non-conformity identified; no previous or actual actions are in place.
 
Event Description
Patient sustained a right hip fracture on (b)(6) 2014 as a result of a fall.Gamma 3 nail was implanted on (b)(6) 2014.Increased pain in the right hip, x-ray showed cut out of lag screw.Patient hospitalized on (b)(6) 2015.Subject had revision surgery on (b)(6) 2015.Reason given for revision was malunion.
 
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Brand Name
TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-24 232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-24 232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4825382
MDR Text Key19304684
Report Number0009610622-2015-00289
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 Other,Study
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/28/2017
Device Catalogue Number31301180S
Device Lot NumberK658200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/04/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight60
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