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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® Ø11X440MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X440MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 35251440S
Device Problem Expiration Date Error (2528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/19/2018
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 l22000007 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¿). 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. Device is implanted.
 
Event Description
Sales associate opened up expired implant. Product expired may 2018. A copy of that sticker was put on the billing form. Implant was grabbed quickly and circulator was not in the room, so the sales associate opened it up at the doctor¿s request without thoroughly inspecting label. The expired device was implanted in the patient.
 
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Brand NameLONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X440MM 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 Key7975327
MDR Text Key124333273
Report Number0009610622-2018-01345
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 Other Health Care Professional
Type of Report Initial
Report Date 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2018
Device Catalogue Number35251440S
Device Lot NumberK02A1D5
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 Received09/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2013
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: 10/17/2018 Patient Sequence Number: 1
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