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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 Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2017
Event Type  malfunction  
Manufacturer Narrative
The evaluation revealed the target device to be the primary product. An investigation and a review of the dhr were not possible due to missing product and missing lot code/serial number. The root cause of the misdrilling could not be determined. 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. Review of complaint history, capa databases, risk analysis and labelling 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
It was reported that after successful implantation of the lag screw, targeting arm still felt loose to the surgeon. Surgeon attempted to lock distally in static mode, but drill bit entered patient anterior to the nail. After attempting several times to target the drill bit through the nail, the surgeon removed the targeting arm and used perfect circular to lock distally. Nail holding screw was checked for tightness prior to removing arm. 20 minute delay in surgery.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that after successful implantation of the lag screw, targeting arm still felt loose to the surgeon. Surgeon attempted to lock distally in static mode, but drill bit entered patient anterior to the nail. After attempting several times to target the drill bit through the nail, the surgeon removed the targeting arm and used perfect circular to lock distally. Nail holding screw was checked for tightness prior to removing arm. Twenty (20) minute delay in 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 Key6752227
MDR Text Key251732587
Report Number0009610622-2017-00237
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
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 09/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number13200100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2017
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: 07/28/2017 Patient Sequence Number: 1
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