• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, STST, RIGHT GAMMA3® Ø11X360MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, STST, RIGHT GAMMA3® Ø11X360MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 42250360S
Device Problem Expiration Date Error (2528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2018
Event Type  malfunction  
Manufacturer Narrative
The reported event was not caused by a deficiency of the device as the expiry date was clearly legible on the label and the usage of the device does not lie in the responsibility of the manufacturer. The expiry date of the implanted device should have been noticed prior to surgery (refer to ifu (b)(4) in chapter sterilization/resterilization: ¿the packaging of all sterile products should be inspected for flaws in the sterile barrier or expiration of shelf life before opening¿). Review of the device history records of the device reported did not indicate any conspicuities; the dhr contain a copy of the label set (label for packaging and patient record label). All labels indicate end of shelf life by (end of) july 2018 (nominal value). Real aging tests performed with stryker implants in 2007 reveal that there is a safety tolerance; implants with exceeded expiry date were checked more than 1 year overdue and considered still sterile subsequently. A consultant hcp stated in a similar case that a risk for the patient is not to be expected although an expired nail (exceeded by approx. 6 months) had been implanted. The expiry date is a theoretical date which offers a high level of safety and the risk of an infection caused by a simple transgression of the expiry date is negligible. Nevertheless, the expiry date of the implanted device should have been noticed prior to surgery. According to available labels in the dhr the expiry date was clearly legible. Furthermore, the implant was hospital-owned at the time of implantation and it should be covered by the hospitals risk management. Thus, evaluation revealed evidence that the event is not linked to a deficiency of the device but is rather related to off-label use and has to be classified as user-customer-shelf-life exceeded. Remains implanted.
 
Event Description
The hospital reported to the sales rep the following event : "implementation of a gamma 3 nail. Ibode noticed that the expiry date of the gamma nail had expired. The surgeon chose to implant the device anyway.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLONG NAIL KIT R2.0, STST, RIGHT GAMMA3® Ø11X360MM 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 Key8246082
MDR Text Key133201531
Report Number0009610622-2019-00048
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K043431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Catalogue Number42250360S
Device Lot NumberK0571CB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2018
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: 01/14/2019 Patient Sequence Number: 1
-
-