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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø9X380 MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø9X380 MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18470938S
Device Problems Off-Label Use (1494); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2016
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The sales representative reported that the surgeon was unable to get the nail off the jig and that the nail holding screw was locked into the nail. The surgeon had to remove the nail from the patient and reinsert a new one. The nail was difficult to remove and the overall process took approximately an additional 2 hours, bringing the total duration of the procedure to between 4 and 5 hours. During the process of removing the nail the customer used and damaged a variety of devices including two t handles, 1 extraction rod and 1 long screwdriver, which were not used for their primary purpose. The nail had to be removed and another nail implanted. This resulted in a 2 hour surgical delay.
 
Manufacturer Narrative
Examination of return product revealed no deficiency. Item did not contribute to event. Thus, concomitant item.
 
Event Description
The sales representative reported that the surgeon was unable to get the nail off the jig and that the nail holding screw was locked into the nail. The surgeon had to remove the nail from the patient and reinsert a new one. The nail was difficult to remove and the overall process took approximately an additional 2 hours, bringing the total duration of the procedure to between 4 and 5 hours. During the process of removing the nail the customer used and damaged a variety of devices including two t handles, 1 extraction rod and 1 long screwdriver, which were not used for their primary purpose. The nail had to be removed and another nail implanted. This resulted in a 2 hour surgical delay.
 
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Brand NameRECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø9X380 MM 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 Key5955504
MDR Text Key55245274
Report Number0009610622-2016-00428
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K032898
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number18470938S
Device Lot NumberK0CF7C4
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2016
Was Device Evaluated by Manufacturer? No
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: 09/16/2016 Patient Sequence Number: 1
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