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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH END CAP, STANDARD T2 HUMERUS Ø6 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER GMBH END CAP, STANDARD T2 HUMERUS Ø6 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18300003S
Device Problem Positioning Failure (1158)
Patient Problem Limb Fracture (4518)
Event Date 09/26/2023
Event Type  Injury  
Event Description
As reported: "in a retrograde case, the timing of compression screw insertion was incorrect.The compression screw was inserted to the front of the dynamic hole with the nail holding screw removed from the nail.Because the device and the nail were not secured, the nail migrated deeply, resulting in a fracture with a third bone fragment when attempting to reattach the device and the nail in the medullary cavity.The nail depth was then readjusted using a universal rod and proximal screw fixation was performed.When compression was attempted with the compression screw after insertion of the distal screw, the compression screw could not move and compression could not be performed, probably due to cross-threading.In addition, because the compression screw had blocked the screw hole, the planned screw could not be inserted and only one distal screw fixation was needed.As for the end cap, it was also implanted with about 2 mm protruding from the nail end due to poor placement of the compression screw." additionally a 60 minute surgical delay was reported.
 
Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device remains implanted.
 
Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.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.With available information no indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
 
Event Description
As reported: "in a retrograde case, the timing of compression screw insertion was incorrect.The compression screw was inserted to the front of the dynamic hole with the nail holding screw removed from the nail.Because the device and the nail were not secured, the nail migrated deeply, resulting in a fracture with a third bone fragment when attempting to reattach the device and the nail in the medullary cavity.The nail depth was then readjusted using a universal rod and proximal screw fixation was performed.When compression was attempted with the compression screw after insertion of the distal screw, the compression screw could not move and compression could not be performed, probably due to cross-threading.In addition, because the compression screw had blocked the screw hole, the planned screw could not be inserted and only one distal screw fixation was needed.As for the end cap, it was also implanted with about 2 mm protruding from the nail end due to poor placement of the compression screw." additionally a 60 minute surgical delay was reported.
 
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Brand Name
END CAP, STANDARD T2 HUMERUS Ø6 MM
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
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 Key17971556
MDR Text Key326125287
Report Number0009610622-2023-00361
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540201140
UDI-Public04546540201140
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number18300003S
Device Lot NumberK1055CE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age47 YR
Patient SexMale
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