Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 31251180S
Device Problems Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017)
Patient Problems Bone Fracture(s) (1870); Injury (2348)
Event Date 12/01/2019
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available for return, device is still implanted.
 
Event Description
The customer reported that they were implanting an 11mm gamma nail into a patient on the left side and as they put the nail in it felt tight.Instead of reaming further, they hit it resulting in a hairline split down the lateral cortex of the femur, going down about an 8cm length of the bone.This was noticed on the end of procedure final x-ray.The surgeon was happy with the reduction of the original fracture using this device and as such they decided to leave the implant in situ.They completed the case by opening the patient up and putting 3 cables around the hairline fracture.The patient will be advised to touch weight bear and not fully weight bear.There was a 45 minute delay to surgery.The surgeon was new to the use of these nails.
 
Manufacturer Narrative
Correction: refer to h6 device code.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device and x-rays must be available in order to determine the root cause of the complaint event.Based on the risk management the most probable root cause of the complaint would be handling failure (medullary canal is not reamed wide enough, or entry point is not correct, too much force used).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
The customer reported that they were implanting an 11mm gamma nail into a patient on the left side and as they put the nail in it felt tight.Instead of reaming further, they hit it resulting in a hairline split down the lateral cortex of the femur, going down about an 8cm length of the bone.This was noticed on the end of procedure final x-ray.The surgeon was happy with the reduction of the original fracture using this device and as such they decided to leave the implant in situ.They completed the case by opening the patient up and putting 3 cables around the hairline fracture.The patient will be advised to touch weight bear and not fully weight bear.There was a 45 minute delay to surgery.The surgeon was new to the use of these nails.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE  D-24232
MDR Report Key9513719
MDR Text Key178379651
Report Number0009610622-2019-00984
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 03/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2024
Device Catalogue Number31251180S
Device Lot NumberK08F8BB
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/01/2019
Initial Date FDA Received12/23/2019
Supplement Dates Manufacturer Received02/17/2020
Supplement Dates FDA Received03/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-