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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X70 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X70 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965070S
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 11/12/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device was discarded.
 
Event Description
After the surgery, the physician felt there was not good enough bending action for patient's knee under xray and complete the procedure. Then it was confirmed by ct there was went through the patella by outer screw and it was reason for not good bending of the patients' knee. So removed the screw. In this time, there was improved bending action.
 
Manufacturer Narrative
Evaluation revealed the supracondylar nail t2 scn and the locking screws to be the primary products. No further associated products were reported. A physical examination could not be carried out as the devices were not received for evaluation. According to information received the supracondylar nail was still implanted whereas the locking screw had been discarded by the customer. A review of the device history records revealed no deviation in the manufacturing process. The devices were documented as faultless prior to distribution. Thus, we excluded deviations in material and manufacturing. In the case presented a patient had been treated with a supracondylar nail t2 scn. During the surgery the attending surgeon diagnosed an insufficient degree of freedom in the patient¿s knee via x-rays while bending. Ct radiographs were taken after the surgery showing the distal locking screw to have gone through the patella causing the limited motion. The distal locking screw was removed, which resolved the limited bending freedom. The received x-ray was forwarded to a consultant hcp for review, who confirmed that the distal locking screw had been inserted into the patellar surface by mistake. Based on the above the event was not linked to a deficiency of the devices, but was rather user related (incorrect implantation/ positioning of the distal locking screw). With available information a deficiency of the devices could not be verified. The file will be closed formally. In case relevant clinical information or the items should become available, we reserve the right to update the investigation and change the root cause. Review of complaint history, capa databases and risk analysis did not identify any discrepancies. There are no open actions in place related to the reported event for the subject products.
 
Event Description
After the surgery, the physician felt there was not good enough bending action for patient's knee under xray and complete the procedure. Then it was confirmed by ct there was went through the patella by outer screw and it was reason for not good bending of the patients' knee. So removed the screw. In this time, there was improved bending action.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X70 MM
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 Key6149751
MDR Text Key61593400
Report Number0009610622-2016-00608
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K032244
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 02/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2021
Device Catalogue Number18965070S
Device Lot NumberK041531
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 Received01/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2016
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: 12/06/2016 Patient Sequence Number: 1
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