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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN T2 NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Failure to Disconnect (2541)
Patient Problems Myocardial Infarction (1969); Discomfort (2330)
Event Date 03/29/2019
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device evaluated by mfr: device disposition is unknown.
 
Event Description
The pharmacist from the hospital reported the following event : "patient (b)(6), female, (b)(6). When using the nail, the nail does not come off the nail holder. The problem had already occurred, the equipment was exchanged with the laboratory and the problem recurred. Laboratory notified and brought us a new nail holder with locking screws. Use of another instrument panel. New information received on may 13th 2019 indicated that there was an impact on the patient, especially during the first procedure. As a reminder, it was an open leg fracture, but totally accessible to a centro-medullary nailing. Surgeon approached and drilled the upper end of the tibia, he made a complete bore of the tibia (for nothing. For information: risk of increased fat embolism due to the use of a sheet), before he realized that the nail instrument was not working and therefore change the means of fixation (so: external fixator). There was a loss of time of about 30 minutes, the time to look for other boxes, to realize that they were not working either, to call (b)(6) to "help us out", to have the external fixer box looked for. During the 1st operation, after removing the instrument set from the t2 nail (nail locking screw stuck in the nail holder), then from the s2 nail (nail locking screw too long for the nail holder), i finally installed an external hoffman fixator. " the consequences for the patient are therefore a double anesthesia (2 operations instead of 1), and an extended operating time for the 1st operation. During the 2nd operation, the same problem. But the managers were very reactive to find an operational instrument. The 2nd operation (definitive nailing) took place 15 days later, with an extended hospital stay, increased discomfort for the patient due to the external fixator, in this elderly and fragile patient. In addition, between the two operations, patient suffered a myocardial infarction, with a stay in cardiological intensive care, whose imputability for the surgery is difficult to prove. (this is my opinion as an orthopedic surgeon, the opinion of an expert doctor could differ. ). This will be reported under separate pi.
 
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Brand NameUNKNOWN T2 NAIL
Type of DeviceIMPLANT
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 Key8680258
MDR Text Key147568667
Report Number0009610622-2019-00479
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
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 Received05/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/07/2019 Patient Sequence Number: 1
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