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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE ARTHRODESIS NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Deformity/ Disfigurement (2360)
Event Date 06/12/2020
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. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a post market clinical follow-up report received from (b)(6) hospital, in usa. The title of this report is ¿a retrospective data collection of the treatment of the ankle with the t2 ankle arthrodesis nailing system¿ which is associated with the stryker ¿t2 ankle arthrodesis nailing¿ system. This report includes research done on 127 patients between the period april, 2019 and january, 2020. It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints. Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report. This product inquiry addresses metatarsal fracture and foot wounds which led to infection and eventual implant removal and below knee amputation. The report states: ¿(b)(6) year old female with recurrent infections, spina bifida, obesity, and tobacco use underwent ttc for complications and arthropathy after previous attempted subatalar fusion at outside hospital. Also underwent previous triple arthrodesis but had residual deformity. Patient underwent pantalar fusion with ttc nail. Patient developed fracture of tibia intraoperatively. Reached union 165 days postoperatively [reported in separately]. Of note and not related to implant, she later developed metatarsal fractures and foot wounds that led to an infection and eventual implant removal and below knee amputation. ¿.
 
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Brand NameUNKNOWN T2 ANKLE ARTHRODESIS NAIL
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10305526
MDR Text Key199923092
Report Number0009610622-2020-00348
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 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received06/24/2020
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: 07/21/2020 Patient Sequence Number: 1
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