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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® 300X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® 300X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 13200100
Device Problem Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/06/2016
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It is reported by the nurse of the hospital, that a distal locking is not possible. Drill running behind the nail. Free hand locking. The customer has upon receipt of the target sleeve no longer misdrillings reported and does not want to exchange the target device. Sales rep. Also discussed with the chief physician because of this current case, to switch the nails of 200 mm to 180 mm in order to prevent further incorrect drilling in this area. The change takes place later this week.
 
Manufacturer Narrative
The evaluation revealed the target device to be the primary product; the provided sleeve and knob were found fully functional. An inspection and a review of the dhr for the target device were not possible because the target device and the lot code were not provided. The customer reported that the target device functioned like specified with a new speedlock sleeve; the complained misdrilling was no longer given; the customer confirmed the target device as fully functional. Because the target device was not returned and the provided sleeve and knob were found fully functional the reported misdrilling was not reproducible and could not be confirmed. 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. : ¿ no fully tightened nail holding screw, ¿ bending forces to the drill / drill sleeve during drilling, ¿ drill sleeve has no contact to the bone surface, ¿ usage of worn drills. Regarding misdrilling the operative technique has already been modified by ecn (b)(4). Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure. The development of a new targeting sleeve with integrated clamping function (combination of sleeve and knob) is completed and resulted in a new device (gamma3 speedlock sleeve). Starting in july 2009, the speedlock sleeve has been available to all markets. The former targeting sleeve and the knob are phased out. 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. Device was not returned.
 
Event Description
It is reported by the nurse of the hospital, that a distal locking is not possible. Drill running behind the nail. Free hand locking. The customer has upon receipt of the target sleeve no longer missdrillings reported and does not want to exchange the target device. Sales rep. Also discussed with the chief physician because of this current case, to switch the nails of 200 mm to 180 mm in order to prevent further incorrect drilling in this area. The change takes place later this week.
 
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Brand NameTARGET DEVICE GAMMA3® 300X160MM
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 Key5628235
MDR Text Key44778609
Report Number0009610622-2016-00230
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 04/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number13200100
Device Lot NumberKHI1070668
Was Device Available for Evaluation? No
Date Returned to Manufacturer04/25/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/03/2016 Patient Sequence Number: 1
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