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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 Ø5X45 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1896-5045S
Device Problems Break (1069); Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 09/01/2021
Event Type  Injury  
Manufacturer Narrative
The event could be confirmed, since the screw was found broken during the investigation. The device inspection revealed the following: the locking screw was returned without allegation against the device. However, the visual inspection has shown that the locking screw is broken apart, the fragment with a length of about 20mm was not returned for evaluation. The typical characteristics of a fatigue fracture could be identified at the fracture face. The origin of the crack was at the right corner, there is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture and then we have a shear lip on the left side, where the final fracture occurred. The relevant dimensions were verified during the investigation and no deviation from the specification could be detected. 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. The locking screw was returned for evaluation and no product related issue could be detected during the investigation. There was no additional information about the event provided, no x-rays and no information about the patient was made available. Therefore the root cause of the breakage cannot be defined. The evaluation of the received screw has shown that fatigue did lead to the breakage of the device. In this relation following statement from the instructions for use (non-active implant) can be pointed out: "these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions. Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing. If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue. Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device. " if more information is provided, the case will be reassessed.
 
Event Description
A gamma nail broke at lag screw hole 4 months post-op. During the inspection one of the returned locking screws was found broken due to fatigue.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14163587
MDR Text Key289697859
Report Number0009610622-2022-00141
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1896-5045S
Device Catalogue Number18965045S
Device Lot NumberK07873B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2020
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: 04/20/2022 Patient Sequence Number: 1
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