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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE T2 RECON ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TARGET DEVICE T2 RECON ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18063100
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/23/2018
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
Customer reported that whilst using t2 recon nail, the registrar and scrub tested to see if they lined up with the jig. They took an x-ray and everything seemed ok, therefore proceeded to drill through the canal. When looking at the lateral view x-ray, they realized the screw missed the nail. They removed the 2 screws and adjusted the nail to try again, but the k-wire hit the nail and small piece of wire broke off. This was left in the patient and they decided not to continue this method. They successfully completed the surgery using antegrade technique by putting the screw through the lesser trochanter. There was a 45 minute delay. Delay of 45 minutes, unintended metal (k-wire) left in patient.
 
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Brand NameTARGET DEVICE T2 RECON
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 Key8182755
MDR Text Key131309352
Report Number0009610622-2018-01519
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K102992
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 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number18063100
Device Lot NumberKME903918
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/19/2018 Patient Sequence Number: 1
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