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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø8X285 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø8X285 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18220828S
Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682)
Patient Problem No Code Available (3191)
Event Date 01/16/2019
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 was undertaking a 2 stage revision of knee and decided to use a gamma nail as a spacer. During the case he inserted the nail and when he inserted one of the screws it was the wrong size. The screw was not fully seated and when the surgeon tried to remove it, it cold welded itself onto the nail. The surgeon left the nail and screw in situ. The reported event resulted in a 2 hour delay to surgery and the surgeon was concerned about the risk of infection due to the length of time the patient was on the table.
 
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Brand NameTIBIAL NAIL, STANDARD T2 TIBIA Ø8X285 MM
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 Key8337604
MDR Text Key136493315
Report Number0009610622-2019-00066
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K003018
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 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number18220828S
Device Lot NumberK0DF76F
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 Received04/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2018
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: 02/13/2019 Patient Sequence Number: 1
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