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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 13200111
Device Problem Mechanics Altered (2984)
Patient Problem No Information (3190)
Event Date 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
Evaluation revealed the target device gamma3® to be the primary device. The reported event of alleged targeting inaccuracy could not be confirmed, since the returned device is conforming to specifications and fully functional. Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure and has to be classified as user-customer-user error. The device inspection revealed the following: the device returned passed the pre-operative function test as intended. Neither a proximal mistargeting nor a distal mistargeting could be confirmed. Nevertheless, with respect to the long service life the device should not be used any longer. Potentially reduced accuracy in guidance is usually found during functional check (required per ifu). In case of any deviation it is realized prior to use. Pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check it was concluded that the event(s) were mainly based in the intra-operative procedure. Reasons for misaligned drilling are various. Potential miss-targeting can also be caused but is not limited by e. G. Loosening of the nail holding bolt during insertion of the nail. Repeated tightening of the nail holding screw prior to distal targeting / drilling is recommended. Not realized unintended loosening of the attachment knob (will lead to release of the drill sleeve). No use of drill with centre tip / unfavourable bone contour. Drilling without drill guiding sleeve. Using blunt or damaged drill. High forces applied to the target device during drilling eventually leading to unintended distortion in the system of drill, sleeve, target device and nail. A review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. No indications of material, manufacturing or design related problems were found during the investigation.
 
Event Description
Missdrilling during dsistal locking. Procedure completed successfully by free hand locking.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
Missdrilling during dsistal locking. Procedure completed successfully by free hand locking.
 
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Brand NameTARGET DEVICE GAMMA3®
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
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7177097
MDR Text Key276660401
Report Number0009610622-2018-00004
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K123401
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 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number13200111
Device Lot NumberKME907632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/09/2018 Patient Sequence Number: 1
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