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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 04/14/2016
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 hospital, that during drilling through the target device the screw holes of the nail can't be hit. As per rep, it was proxmial missdrilling, procedure was successfully completed; not reported how. No adverse consequences. No prolongation of surgery.
 
Manufacturer Narrative
The target device returned is regarded as primary product. The speedlock sleeve returned is regarded as associated 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. The item returned was documented as faultless prior to distribution and as it had been in use for a longer time (approximately 4 years) we pre-suppose that this target device had fulfilled its tasks in former surgeries as intended. The returned target device passed the pre-operative function test as intended. Neither a proximal mistargeting nor a distal mistargeting could 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 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 referring to received information it is suggested that potential deviation in proximal targeting accuracy should have been detected during required functional check prior to use. No information was given which kind of nail had been used. Further, the kind of preparing the intramedullary canal may be essential for inserting the nail without deflection. Depending on the bone curvature, this may contribute to sufficient drilling. Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure. The found deep impacts in the peek material are clearly identified due to hammering onto the device which is regarded as user related. The brochure instructions for cleaning, sterilization, inspection and maintenance (l240020009) shows several examples of damages and recommends removing of such damaged products.
 
Event Description
It is reported by the hospital, that during drilling through the target device the screw holes of the nail can't be hit. As per rep, it was proxmial missdrilling, procedure was successfully completed; not reported how. No adverse consequences. No prolongation of surgery.
 
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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 Key5646711
MDR Text Key45502447
Report Number0009610622-2016-00247
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 04/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number13200100
Device Lot NumberKME904008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2016
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? No
Date Device Manufactured04/04/2012
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: 05/11/2016 Patient Sequence Number: 1
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