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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® Ø10X400MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X400MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 34250400S
Device Problem Expiration Date Error (2528)
Patient Problem No Code Available (3191)
Event Date 08/23/2017
Event Type  malfunction  
Manufacturer Narrative
Evaluation revealed the long nail kit r1. 5, ti, right gamma3® ø10x400mm x 125°to be the primary product. No further associated products were reported. The reported long nail kit was not returned for evaluation as it remained implanted. Furthermore, a physical examination was not required since the issue is about an exceeded expiry date. A review of the device history records revealed no discrepancies. The device was manufactured, packaged, sterilized and labelled like specified. The item was documented as faultless prior to distribution. During investigation no material, design or manufacturing related issues were found. All labels indicate the end of shelf life by (end of) april 2017. In the case presented an expired long nail kit was implanted, which is beyond the manufacturer¿s control. The sterility expiration date was exceeded by approx. 115 days (expiry date on label: april 30, 2017; date event occurred: (b)(6) 2017). Thus, the event does not present a manufacturing and/or labelling issue. Real aging tests performed for sample packaging of the gamma3 nail in 2016 revealed that there is a safety tolerance. Implants with exceeded expiry date were checked and were considered still sterile subsequently. Sufficient seal strength was demonstrated by the conducted peel test of the seal. The seal integrity was approved by microbiological testing of 10 complete packaging systems. Additionally, these results were confirmed by a dye penetration test. The shelf life stability of real time aged sterile packaging could be demonstrated successfully for 8 years and 7 months when stored at 16°c. A medical consultation in a similar case (a nail has been implanted approx. 6 months after expiry date) revealed that any such situation does not require medical intervention and a risk for the patient is not to be expected. 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 exceeded 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 have been covered by the hospitals risk management. Based on the above the event was not linked to a deficiency of the device, but was rather related to off-label use. 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 an expired nail was inserted into patient.
 
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device is implanted.
 
Event Description
It was reported that an expired nail was inserted into patient.
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X400MM 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 Key6877623
MDR Text Key247379778
Report Number0009610622-2017-00292
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 12/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2017
Device Catalogue Number34250400S
Device Lot NumberK102044
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 Received11/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2012
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: 09/19/2017 Patient Sequence Number: 1
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