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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, LEFT GAMMA3® Ø11X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 35251340S
Device Problem Break (1069)
Patient Problems Fall (1848); Injury (2348)
Event Date 12/09/2015
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Hospital policy.
 
Event Description
It was reported that patient had a gamma nail implanted in their hip and patient then fell post operatively and damaged their hip further. Surgeon did a removal of long gamma nail due to post op fall - no hardware was broke however damage was done to patient's hip as a result of the fall requiring another surgery and surgeon removed the gamma nail and replaced with a total hip utilizing the restoration modular system.
 
Manufacturer Narrative
Product inquiry stated the reported long nail kit r1. 5, ti, left gamma3® ø11x340mm x 125° to be the primary product. The other implants reported were considered as concomitant products as they did not contribute to the event reported. Review of the device history records revealed no discrepancies. The long nail kit was documented as faultless prior to distribution. No material, design or manufacturing related issues were found. A physical examination of the items could not be carried out as the devices were not returned to stryker (b)(4) (hospital policy). However, referring to the event description no product deficiency was subject of the event reported. In this case the cause for the implant removal was based on a fall of the patient. After approximately 4 weeks of implantation the patient fell and damaged her hip. The long nail kit was removed and replaced by a total hip. ¿no hardware was broke. However damage was done to patient's hip as a result of the fall requiring another surgery. ¿ the use of a total hip arthroplasty as revision implant leads furthermore to the assumption of a reduced bone quality. General aspects: implant removal may be necessary although no product deficiency is given. Possible reasons could be (but not limited to) non-union, cut-out, motor loss (potentially resulting from a fall) or multi-fractural-situation. Such harms do not primly depend on the implant. It is mostly caused by the kind of fracture, patient's general condition etc. With given information it can be concluded that the revision had to be carried out due a damaged hip. The reported information did not allege any deficiency in the identity, quality, reliability, safety, effectiveness or performance of the device. From technical point of view a further statement was not possible. With available information the cause of the event was most likely based on the patient¿s condition (fall). A deficiency of the product in question could not be verified. In case the products and / or relevant clinical information should become available, we reserve the right to update the investigation and change the root cause. 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
It was reported that patient had a gamma nail implanted in their hip and patient then fell post operatively and damaged their hip further. Surgeon did a removal of long gamma nail due to post op fall - no hardware was broke; however, damage was done to patient's hip as a result of the fall requiring another surgery and surgeon removed the gamma nail and replaced with a total hip utilizing the restoration modular system.
 
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Brand NameLONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X340MM 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 Key5346422
MDR Text Key35161238
Report Number0009610622-2016-00002
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
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 12/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2018
Device Catalogue Number35251340S
Device Lot NumberK0593E5
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 Received03/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2013
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: 01/06/2016 Patient Sequence Number: 1
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