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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X260MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X260MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 34250260S
Device Problems Failure To Adhere Or Bond (1031); Break (1069)
Patient Problem Fall (1848)
Event Date 01/07/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Product has been discarded.
 
Event Description
Primary gamma3 surgery was performed on (b)(6) 2015. After that nonunion was found and the nail was broken when the patient fell at the end of the year of 2015. Revision surgery was performed on (b)(6) 2016.
 
Manufacturer Narrative
Evaluation revealed the reported long nail kit r1. 5, ti, right gamma3® ø10x260mm x 125° to be the primary product. The other products reported are considered associated products, which did not contribute to the event. The devices reported were not returned to stryker kiel; according to information received they were discarded. Thus, a physical examination of the broken nail was not possible. Review of the device history records of the affected nail kit revealed no conspicuities in material or manufacturing. The reported nail has been implanted end of (b)(6) 2015 and was revised beginning of (b)(6) 2016, which means an implantation duration of 10. 5 months. The root cause of the reported event was already stated in the event description: non-union and a fall of the patient end of 2015 had caused the nail breakage. 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 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. Based on the above observations including the information given the nail breakage reported is not linked to a deficiency of the device, but is rather considered patient related (non-union and fall). 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
Primary gamma3 surgery was performed on (b)(6) 2015. After that nonunion was found and the nail was broken when the patient fell at the end of the year of 2015. Revision surgery was performed on (b)(6) 2016.
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X260MM 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 Key5399163
MDR Text Key37130187
Report Number0009610622-2016-00041
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 01/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/30/2019
Device Catalogue Number34250260S
Device Lot NumberK029DA9
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 Received02/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2014
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: 01/29/2016 Patient Sequence Number: 1
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