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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965055S
Device Problem Bent (1059)
Patient Problem No Code Available (3191)
Event Date 11/24/2016
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The customer reported that they had to undertake a second operation to remove a bent t2 nail.
 
Manufacturer Narrative
Evaluation revealed the received reconstruction nail r2. 0 and the locking screw t2 tibia ø5x55 mm to be the subject products. The other two locking screws received were considered as concomitant products as they did not contribute to the event reported. Deficiency in material or manufacturing was not found. External examination of the raw materials prior to manufacturing had confirmed the required mechanical properties. Dimensional examination revealed no deviations in the relevant undamaged areas. The affected items were documented as faultless prior to distribution. During investigation no material, design or manufacturing related issues were found. In the case presented a patient had been treated with a reconstruction nail due to a shaft fracture of the left femur. On (b)(6) 2016 the patient had to be revised as x-rays identified the nail and one locking screw to be deformed/ bent. The received nail was found to have a significant bend starting approximately in the center. The original radius of this nail is r2000. The received nail had an additional bend of approx. 30°. One of the locking screws was found to be slightly deformed/ bent as well. The provided x-rays showed that the bend of the nail had occurred approx. In the center of the femoral bone in the area of a big fracture gap. As there is no bone-to-bone contact in this area, nearly all forces and bending moments at the fracture site were transferred by the nail. The nail is made of titanium alloy which has ductile characteristics / composition. That means that in case high unusual forces are applied to the material, a titanium nail will always get bent before it breaks due to over-bending. In this case the nail had not exceeded the maximum of its tensile strength but applied forces had caused the nail to get plastically deformed. Titanium alloys can break i. E. As a result of a fatigue fracture which is the result of permanent, repeated overload. However, the nail design, material and strength were successfully tested and specified during development; the nails are qualified for their specified application under normal conditions. Referring to the above appearances of the nail, extraordinary high forces are required to cause such a deformation/ bending of a nail. A direct trauma (e. G. Accident, fall), a sudden stumbling or extremely high postoperative loads are the most probable causes. However further information about the event and its circumstances were not provided although requested for several times. As no patient data or information about the post implant activity were available, it could not be determined if the patient had been compliant to the surgeon¿s instructions. The ifu defines additional trauma as potential adverse effects. The ifu also points out that the surgeon has to warn the patient for potential overload. With available information a deficiency of the devices could not be verified. Based on the information given above the cause of the case is attributed to the 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 product. No non-conformity was identified.
 
Event Description
The customer reported that they had to undertake a second operation to remove a bent t2 nail.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X55 MM
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 Key6180375
MDR Text Key62544208
Report Number0009610622-2016-00624
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K032244
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 02/24/2017
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 Date07/31/2021
Device Catalogue Number18965055S
Device Lot NumberK0BF9D4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2016
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
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