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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 30600095S
Device Problem Cut In Material (2454)
Patient Problem Bone Fracture(s) (1870)
Event Date 02/18/2015
Event Type  Injury  
Event Description
Gamma lag screw cut out.Screw taken out, original fracture was healed.Surgeon wanted to change both the gamma nail and lag screw but noticed that the fracture had healed and left only the nail in place without a lag screw to avoid another fracture.
 
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
 
Manufacturer Narrative
Physical examination was not possible because no item was returned.The review of the manufacturing documents revealed no manufacturing issue.The review of the risk analysis revealed that cut-out / medialization had been considered.The occurrence threshold was not exceeded.Investigation revealed no non-conformity; therefore no new capa was initiated.The event description did not identify product damage.According to received information the event occurred approx.11 months after initial implantation.It was reported that the initial bone fracture had healed but after the patient had allegedly experienced a cut-out.A deficiency of any implant was not reported.In this case the implants had fulfilled their task ¿ temporary stabilization of bone fracture ¿ without any reported discrepancy.The original fracture had healed.Due to missing medical information it could not be determined whether the event actually presented a cut-out or rather a medialization of the lag screw.In case of a cut-out the femur neck slips over the lag screw ¿ in most of the cases due to torsional displacement and poor bone substances (mostly patient related).In case of medialization the lag screw proceeds into and sometime penetrates the femur head ¿ in most of the reported cases an insufficiently placed set screw has been the root cause (mostly user related).In both cases the lag screw may protrude the femur head in superior direction.However, both events will not be caused by any deficiency of the device(s).With available information the event was not caused by any deficiency of the device.A real root course could not be determined.No medical records were available for review.In case relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.
 
Event Description
Gamma lag screw cut out.Screw taken out, original fracture was healed.Surgeon wanted to change both the gamma nail and lag screw but noticed that the fracture had healed and left only the nail in place without a lag screw to avoid another fracture.
 
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Brand Name
LAG SCREW, TI GAMMA3® Ø10.5X95MM
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 Key4580618
MDR Text Key5340791
Report Number0009610622-2015-00100
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/31/2018
Device Catalogue Number30600095S
Device Lot NumberK0E7C1D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2014
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 Age81 YR
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