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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 Ø5X35 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965035S
Device Problems Break (1069); Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2019
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
 
Event Description
It was reported that the patient's left femur was revised due to metal fatigue causing the gamma nail to break at the junction with the lag screw.
 
Event Description
It was reported that the patient's left femur was revised due to metal fatigue causing the gamma nail to break at the junction with the lag screw.
 
Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
 
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Brand Name
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM
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 Key8709676
MDR Text Key148404989
Report Number0009610622-2019-00493
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540202482
UDI-Public04546540202482
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
Type of Report Initial,Followup
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number18965035S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/28/2019
Initial Date FDA Received06/18/2019
Supplement Dates Manufacturer Received06/24/2019
Supplement Dates FDA Received07/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age79 YR
Patient Weight73
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