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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 FEMORAL NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN T2 FEMORAL NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Separation Problem (4043)
Patient Problems Failure of Implant (1924); Implant Pain (4561)
Event Date 09/15/2020
Event Type  Injury  
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. 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. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated.
 
Event Description
The manufacturer became aware of a post market clinical follow-up report received from university of (b)(4), in usa. The title of this report is ¿a retrospective data collection of the treatment of femur fractures with the t2 femoral nailing system¿ which is associated with the stryker ¿t2 femoral nailing system¿. This study includes research done on 52 patients requiring surgery between the period february 15, 2017 to september 1, 2019. It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints. Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report. This product inquiry addresses pain due to distal interlocking screw back out for which screw removal was performed. The report states: ¿patient fourteen who sustained a grade 3a femur fracture was discovered to have limb length discrepancy of the affected extremity as compared to the contralateral side. An attempt to correct the limb length intraoperatively was unsuccessful. The patient then returned to the operating room 2 days later for revision of the limb length inequality. Following the revision surgery, the patient was clinically identified to have symmetric limb lengths [reported separately]. The patient then presented one month postoperatively with pain in his right knee as a result of a distal interlocking screw backing out. The patient returned to the operating room for hardware removal of the prominent interlocking screw. The pain has since resolved advised to follow-up on an as-needed basis. ¿.
 
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Brand NameUNKNOWN T2 FEMORAL NAIL
Type of DeviceIMPLANT
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 Key10738069
MDR Text Key213244550
Report Number0009610622-2020-00610
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial
Report Date 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
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 Received09/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/26/2020 Patient Sequence Number: 1
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