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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL END CAP, SCN T2 SCN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL END CAP, SCN T2 SCN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18260003S
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2018
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
At (b)(6) 2018, operation with t2scn was done.After the operation, the end cap was came out and the most distal condyle screw was backed out.Therefore, at (b)(6) 2018, the end cap and condyle screw was removed and new same devices were implanted.
 
Event Description
At (b)(6) 2018, operation with t2scn was done.After the operation, the end cap was came out and the most distal condyle screw was backed out.Therefore, at (b)(6) 2018, the end cap and condyle screw was removed and new same devices were implanted.
 
Manufacturer Narrative
The reported event that end cap, scn t2 scn was alleged of implant migration could not be confirmed.Although x-rays were repeatedly requested but not provided until time of investigation closure and thus, the reported event of unintended movement of end cap after implantation could not be verified.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: we received an end cap, scn t2 scn for evaluation.Detailed visual inspection revealed clear signs of usage.The windings show material abrasion [slight dents] and the inner side of hexagon shows scratches.Due to the nature of the returned device, a functional inspection was not possible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.
 
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Brand Name
END CAP, SCN T2 SCN
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key8075190
MDR Text Key127346514
Report Number0009610622-2018-01397
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540378613
UDI-Public04546540378613
Combination Product (y/n)N
PMA/PMN Number
K023267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/31/2023
Device Catalogue Number18260003S
Device Lot NumberK0973BF
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2018
Date Manufacturer Received01/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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