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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 34250340S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Bone Fracture(s) (1870)
Event Date 05/02/2018
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device remains implanted.
 
Event Description
During gamma3 surgery, the nail tip perforated anterior cortical bone. Since it was found after lag screw was completely implanted, the surgeon did not attempt re-insertion the nail. The surgery was finished after implantation of a locking screw. In the surgeon's opinion, the patient's cortical bone was very thin.
 
Manufacturer Narrative
The reported event that long nail kit r1. 5, ti, right gamma3® ø10x340mm x 125° was alleged of 'adverse impact on patient / patient related / iatrogenic issue' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided. Based on investigation, the root cause was attributed to be user related. The failure was caused by implanting the device in a bone stock compromised by disease. Indeed, the reported event is an iatrogenic fracture, which is not the device's fault. As a reminder, the ifu states: " ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system. Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments. For your information, avail yourself of the training courses and publications offered (e. G. Operative techniques)," as well as: " bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/ or fixation of the devices. " 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. If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
During gamma3 surgery, the nail tip perforated anterior cortical bone. Since it was found after lag screw was completely implanted, the surgeon did not attempt re-insertion the nail. The surgery was finished after implantation of a locking screw. In the surgeon's opinion, the patient's cortical bone was very thin.
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X340MM X 125°
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key7555182
MDR Text Key109617136
Report Number0009610622-2018-00228
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number34250340S
Device Lot NumberK0A3B1A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/30/2018 Patient Sequence Number: 1
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