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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON Ø12X320 MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON Ø12X320 MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18431232S
Device Problem Break (1069)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 12/04/2017
Event Type  Injury  
Manufacturer Narrative
The reported event that reconstruction nail r1. 5, ti, left t2 recon ø12x320 mm x 125° was alleged of issue (implant breakage - nail) 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 must be available in order to determine the root cause of the complaint event. General aspects: the t2 recon nail is a temporary implant which inevitably will be subject of a fatigue fracture if the biomechanical stresses on the implant are too high or not considerably reduced during the period of implantation. During this period there is a race between bony consolidation / fracture healing and implant breakage as noted in the labelling of the product. Usually a breakage is contributed by one or more deficits, e. G. Insufficient bone healing, product damage. Generally, the risk of a breakage will increase with the increase of load cycles and load level. Nail breakage in general has been experienced but does not present an unanticipated event in itself. Depending on load application, also, depending on the patient¿s post implant behavior and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e. G. Increased post-operative activities - a nail breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other. One requirement for successful nail treatment is a timely bone healing in order to relive the implants over the progressing time of implantation. Another requirement is that the implant must not be damaged during and after insertion. Surface damages reduce the implant¿s durability significantly. A third requirement is that the implant must not be stressed by too high load application e. G. (but not limited to) exceeding weight bearing or overweight or other stresses. The device inspection was not possible as the product was not returned for investigation. 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 material, manufacturing or design related problems were found during the investigation. A review of the labeling did not indicate any abnormalities. If device is returned or any further information is provided, the investigation report will be reassessed.
 
Event Description
The patient underwent hansson pin lock surgery on (b)(6) 2017, and then she fell down and subtrochanteric fracture occurred. Therefore, revision surgery was performed using t2 reconstruction nail on (b)(6) 2017. In (b)(6) 2017, the t2 reconstruction nail was broken due to pseudoarticulation. On (b)(6) 2017, revision surgery was performed. During the surgery, extraction of the distal nail was attempted using extraction hook small and slide hummer, but the tip hook was broke inside the bone. The distal nail was removed with ball-tipped and smooth-tipped guidewire, and the tip hook was retrieved using suction tube and teflon tube.
 
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device was discarded.
 
Event Description
The patient underwent hansson pin lock surgery on (b)(6) 2017, and then she fell down and subtrochanteric fracture occurred. Therefore, revision surgery was performed using t2 reconstruction nail on (b)(6) 2017. In (b)(6) 2017, the t2 reconstruction nail was broken due to pseudoarticulation. On (b)(6)2017, revision surgery was performed. During the surgery, extraction of the distal nail was attempted using extraction hook small and slide hummer, but the tip hook was broke inside the bone. The distal nail was removed with ball-tipped and smooth-tipped guidewire, and the tip hook was retrieved using suction tube and teflon tube.
 
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Brand NameRECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON Ø12X320 MM 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 Key7153136
MDR Text Key248375051
Report Number0009610622-2017-00385
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K102992
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 09/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2021
Device Catalogue Number18431232S
Device Lot NumberKOA65E6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/08/2016
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: 12/28/2017 Patient Sequence Number: 1
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