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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 Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2016
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
Exact distal locking is not possible anymore.
 
Manufacturer Narrative
Evaluation revealed the target device as primary product. The speedlock sleeve returned was classified as concomitant product. Appearance of item and inspection records identified the target device returned being of new design version. Deviations in the inspection documents were not found. A check of the function on 100% of the devices (sub-supplier) and additional in-house spot check of the lot in question revealed function was given in full on the devices at the stage of delivery. Functional test revealed neither proximal ¿ nor distal contacts of the drill to the drill holes of the sample nail. The function of the target device returned was fully given. A mis-targeting could not be reproduced during performed pre-operative check. The alleged event ¿exact distal locking is not possible anymore¿ could not be confirmed. 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 and misaligned distal locking screws are various. Potential miss-targeting can also be caused but is not limited by e. G. Ensure that the nail holding bolt is still fully tightened. Avoid soft tissue pressure on the distal locking sleeve assembly- therefore the skin incision would be made (co-linear) in direction of the sleeve assembly. Check that the distal locking sleeve assembly with the trocar removed is in contact with the lateral cortex of the femur and is locked securely with the speedlock sleeve knob. Confirm final locking screw placement with a/p and lateral fluoroscopic x-ray. Neutralize the power tool weight during drilling procedure and do not apply force to the targeting arm start the power tool before having bone contact with the drill use sharp and center tipped drills only. Regarding misdrilling the operative technique has already been modified by engineering change. Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure. The event did not involve a product problem indicating a non-conformity, adverse trend or unanticipated hazard. Investigation revealed no non-conformity, therefore no ncr was initiated. A review of the labeling did not indicate any abnormalities.
 
Event Description
Exact distal locking is not possible anymore.
 
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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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6179514
MDR Text Key62541548
Report Number0009610622-2016-00619
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 03/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number13200111
Device Lot NumberKME907260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2015
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: 12/15/2016 Patient Sequence Number: 1
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