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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X90MM IMPLANT

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STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X90MM IMPLANT Back to Search Results
Catalog Number 30660090S
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 09/27/2016
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
On (b)(6) 2016, the patient underwent the surgery with the g3 nail. On (b)(6) 2016, the surgeon confirmed x-ray. And he found that the cut out of u-lag screw. Therefore the surgeon is planning the revision surgery by tha on (b)(6) 2016.
 
Manufacturer Narrative
The evaluation revealed the u-blade set and nail kit to be the primary products. No deviations were found during review of the manufacturing and inspection documents (dhr). The implants returned were documented as faultless prior to distribution. During investigation no material, design or manufacturing related issues were found. Except for the drill marked proximal nail hole no damages were found on the provided implants; they could be assembled like specified. The thread marked plastic ring of the set screw and imprints on the set screw tip and proximal lag screw flute indicate that the lag screw was correctly secured by the set screw. Furthermore the u-blade end cap was also set correctly based on the thread-marked plastic inlay. The function was fully given. According to a health care professional the fracture is an intra-capsular (medial) femur neck-fracture. Medial neck-fractures are explicitly listed as contraindications according to the operative technique. Under postoperative load the necrotic bone material was not strong enough to hold the u-blade lag screw so finally it cut through the femur head after approx. Two months. Necrosis and weak bone material can lead to implant failures like cut outs and are listed as adverse effects in the ifu. Furthermore the operative technique defines medial neck fractures as contraindication. Based on the given facts the case is attributed to the user (wrong treatment, deviation from surgical technique), contributed by the patient (necrotic bone material); a manufacturer related issue can be excluded. Review of complaint history, capa databases and risk analysis did not identify any discrepancies. There are no open actions in place related to the reported event for the subject product(s). No non-conformity was identified.
 
Event Description
On (b)(6) 2016, the patient underwent the surgery with the g3 nail. On (b)(6) 2016, the surgeon confirmed x-ray. And he found that the cut out of u-lag screw. Therefore the surgeon is planning the revision surgery by tha on (b)(6) 2016.
 
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Brand NameU-BLADE SET, TI GAMMA3® Ø10.5X90MM
Type of DeviceIMPLANT
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 Key6055877
MDR Text Key58356753
Report Number0009610622-2016-00485
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K043431
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 02/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number30660090S
Device Lot NumberK0C5267
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2016
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: 10/25/2016 Patient Sequence Number: 1
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