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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADJUSTING DEVICE TIBIA T2 ALPHA TIBIA ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL ADJUSTING DEVICE TIBIA T2 ALPHA TIBIA ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2353-4105
Device Problems Component Missing (2306); Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided. The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated. A review of the labeling did not indicate any abnormalities. The instructions for use instructs user that: ¿before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other. ¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. However, based on risk management file review, possible cause of failure could be user related issue- the adjusting device pin was missing (loss during cleaning and checking set), without which adjusting device cannot be attached to target device for distal drilling. If device is returned or any further information is provided, the investigation report will be reassessed.
 
Event Description
As reported: "the distal adjusting device pin was missing. The doctor didn't notice it, and a drill was inserted in the ankle surface. Miss drilling has occurred. ".
 
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Brand NameADJUSTING DEVICE TIBIA T2 ALPHA TIBIA
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10701923
MDR Text Key219335355
Report Number0009610622-2020-00567
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K191271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2353-4105
Device Catalogue Number23534105
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 Received09/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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