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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN Ø10X400MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN Ø10X400MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18261040S
Device Problems Off-Label Use (1494); Expiration Date Error (2528)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 07/05/2019
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device remains implanted.
 
Event Description
The surgeon reported that he implanted a supracondylar nail into a patient which had expired in may 31st 2019. The surgeon was aware that the implant was past its expiry date at the point of implantation, but there was no alternative available.
 
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Brand NameSUPRACONDYLAR NAIL T2 SCN Ø10X400MM
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
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8837921
MDR Text Key153274534
Report Number0009610622-2019-00575
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K023267
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 11/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Catalogue Number18261040S
Device Lot NumberK098BF3
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 Received11/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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