• 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 LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X360MM 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 LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X360MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 33250360S
Device Problems Break (1069); Fracture (1260)
Patient Problem Fall (1848)
Event Date 11/23/2016
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that patient fell on (b)(6) 2016 with adiposity per magna (bmi56) with subtrochanteric fracture and a broken gamma nail in the area of drilled hole for the femoral head screw.
 
Manufacturer Narrative
Evaluation revealed the broken long nail to be the primary product. The other devices reported are considered associated products. Failures in material or manufacturing were not found. Review of the dhr for the reported nail kit revealed no discrepancies; the device was documented faultless prior to distribution. Dimensional examination revealed no deviations in the relevant undamaged areas of the nail received. The received nail is completely broken in the webs of the proximal lag screw thru hole. According to the damage and the evidences of the breakage surfaces, the nail broke in a fatigue fracture. However, significant drill marks are found at the lateral entrance of the proximal thru hole for the lag screw at the anterior web; they progress through the entire bore towards medial. The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture by a notching effect at the lateral edge of the anterior web. Friction marks at the medial / distal and the lateral / proximal edge of the lag screw thru hole of the nail indicates high tension forces caused by high axial load - transmitted by the lag screw. The affected nail is designed to withstand the normal loads during the implantation period, i. E. , the implant must neither be exposed to peak loads nor to continuous stresses. Another prerequisite for a successful supply is undisturbed, normal bone healing. This state must be achieved within a medically recognized and by scientific analysis confirmed period (about 6 months) in such way, that the bone strength allows significantly increasing discharge of the implant material. In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications. The (b)(6) patient, who suffered from adiposity per magna (b)(6), fell on (b)(6) 2016 after an implant residence time of 26 months. Nevertheless, densely staggered lines of rest on the breakage surfaces clearly indicate a fatigue fracture which was most likely initiated by intra-operative damage by a deviated step drill (notching effect) according to the damage pattern. Referring to the appearance of the residual fracture (in particular at the anterior web) the final separation was most likely caused by the fall of the obese patient. However, impaired bone healing cannot be excluded referring to the long implant residence time. Based on the above the breakage of the nail is not linked to a deficiency of the device, but is rather considered patient related contributed by intra-operative damage by a deviated step drill. The long implant residence time in conjunction with extreme overweight and the resulting prolonged overload had led to continuous stresses and a significant weakening of the nail in the area of the lag screw thru hole followed by the fatigue fracture. The final separation was most likely caused by the fall of the obese patient. Review of complaint history, capa databases and risk analysis did not identify any conspicuity. The review of the risk assessment for the failure mode indicated the issue was addressed adequately. There are no actions in place related to the reported event for the subject products.
 
Event Description
It was reported that patient fell on (b)(6) 2016 with adiposity per magna (b)(6) with subtrochanic fracture and a broken gamma nail in the area of drilled hole for the femoral head screw.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X360MM 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
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 Key6180342
MDR Text Key62545201
Report Number0009610622-2016-00623
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2017
Device Catalogue Number33250360S
Device Lot NumberK572726
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/12/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2016 Patient Sequence Number: 1
-
-