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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW T2 TIBIA SPI; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL NAIL HOLDING SCREW T2 TIBIA SPI; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1806-1401
Device Problem Mechanical Jam (2983)
Patient Problem Insufficient Information (4580)
Event Date 05/29/2022
Event Type  Injury  
Event Description
It was reported that whilst connecting a t2 tibial nail to the t2 suprapatella nail adaptor, the surgeon noted that although the nail was correctly aligned with the adaptor, it still had some movement.He tightened the bolt as much as he could to no avail.He decided to remove the bolt and try again only to find that this was not possible.The bolt appeared to have cold welded into the nail.The surgeon had to switch to the infrapatella incision.He had already completed reaming through the suprapatella incision so the change was relatively simple.He reamed to the next nail diameter and inserted the nail using the t2 infrapatella nail adaptor.There was a delay of about 10 minutes in the procedure whilst the surgeon tried to separate the nail from the bolt.The patient was adversely affected, as an extra incision had to be made to accommodate the new entry point for the nail.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that whilst connecting a t2 tibial nail to the t2 suprapatella nail adaptor, the surgeon noted that although the nail was correctly aligned with the adaptor, it still had some movement.He tightened the bolt as much as he could to no avail.He decided to remove the bolt and try again only to find that this was not possible.The bolt appeared to have cold welded into the nail.The surgeon had to switch to the infrapatella incision.He had already completed reaming through the suprapatella incision so the change was relatively simple.He reamed to the next nail diameter and inserted the nail using the t2 infrapatella nail adaptor.There was a delay of about 10 minutes in the procedure whilst the surgeon tried to separate the nail from the bolt.The patient was adversely affected, as an extra incision had to be made to accommodate the new entry point for the nail.
 
Manufacturer Narrative
Please note correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition unknown.
 
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Brand Name
NAIL HOLDING SCREW T2 TIBIA SPI
Type of Device
ROD, 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 Key14787873
MDR Text Key294939411
Report Number0009610622-2022-00277
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07613327005394
UDI-Public07613327005394
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K131365
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 08/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1806-1401
Device Catalogue Number18061401
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2022
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
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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