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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

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 31251180S
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 11/15/2016
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
G3 nail broke.
 
Manufacturer Narrative
Evaluation revealed the received trochanteric nail kit ti gamma3 ø11x180mm x 125° to be the primary product. The lag screw ti gamma3 ø10. 5x80mm received was considered as a concomitant product as it did not contribute to the event reported. Deficiency in material or manufacturing was not found. Dimensional examination revealed no deviations in the relevant undamaged areas. The affected item was documented as faultless prior to distribution. Thus, we excluded deviations in material and manufacturing. In the case presented a patient had been treated with a trochanteric nail kit on (b)(6) 2016 due to a per-trochanteric fracture of the left femur, which had occurred due to a fall in the bathroom. On (b)(6) 2016 the patient had to be revised as the trochanteric nail was found to be broken. According to information received from the patient another fall in the bathroom had been experienced. The broken nail had been removed and replaced by another trochanteric nail. The received nail was completely broken in the webs of the proximal drill hole for the lag screw. According to the damage and the evidences of the breakage surfaces the nail broke in a fatigue manner after an implantation period of 23 weeks. Mechanical damages and significant drill marks at the lateral edge as well as inside the proximal drill hole of the anterior web had been caused by the contact with the step drill. Such damages may cause additional notch effects. The incipient crack most likely had started at the anterior web at lateral within the drill marked area and had progressed towards medial. The appearance of the breakage surfaces (smooth topography at lateral becoming rougher towards medial) suggested that the nail had broken in a fatigue manner ¿ indicated by lines of rest (running from lateral to medial) and missing plastic deformation. Bearing points are typical results of the interaction of the single products and the bone during the implantation period. Significant bearing points at the inferior edge of the proximal drill hole at medial as well as at the superior edge at lateral were found - transmitted by the lag screw. The appearance identified a high axial load application to the implants. A nail will be subject of a fatigue fracture if the stresses on the implant are too high or not considerably reduced during the period of implantation. The affected implant 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 period (confirmed by scientific analysis about 6 months) in such way, that the bone strength allows significantly increasing discharge of the time-fixed 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. One requirement for successful nail treatment is a timely bone healing in order to relive the nail over the progressing time of implantation. Another requirement is that the implant must not be stressed by too high load application e. G. (but not limited to) exceeding weight bearing or other stresses. In the given case the patient had experienced a fall in the bathroom leading to the breakage of the nail. Traumatic overloads, postoperatively loads and intra-operatively implant damages are adverse effects that can lead to implant breakages and are listed in the ifu and operative technique. Based on the above the nail breakage was not linked to a deficiency of the device, but was rather patient related (traumatic overload as a result from a fall), which might have been contributed by the intra-operative damage of the nail caused by a deviated step drill. 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
G3 nail broke.
 
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Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM 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 Key6149753
MDR Text Key61592651
Report Number0009610622-2016-00607
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 03/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number31251180S
Device Lot NumberK0D41E1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/31/2016
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: 12/06/2016 Patient Sequence Number: 1
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