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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE LOCKING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE LOCKING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNK_KIE
Device Problems Break (1069); Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 04/01/2018
Event Type  malfunction  
Event Description
The manufacturer became aware of a literature published by the department of orthopedic surgery, the affiliated drum tower hospital of nanjing university medical school, china. The title of this report is ¿reconstruction of bone defect with allograft and retrograde intramedullary nail for distal tibia osteosarcoma¿, published on april 01, 2018, which is associated with the stryker ¿t2 ankle locking screw¿. The article can be found at http://dx. Doi. Org/10. 1016/j. Fas. 2017. 01. 006. This report includes analysis of the clinical data that was collected on 5 patients, and the cases in this study range from march 2010 to may 2014. During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available. It was reported that 1 patient experienced screw breakage. The report states, ¿besides, screw breakage was found at 4 years after surgery in patient no. 1. Considering that excellent fusion had been achieved, we performed no treatment to the fractured screw, and no complaint was reported by the patient in the follow-up. ¿.
 
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report.
 
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Brand NameUNKNOWN T2 ANKLE LOCKING SCREW
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 Key14112185
MDR Text Key289272434
Report Number0009610622-2022-00136
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Literature
Reporter Occupation
Type of Report Initial
Report Date 04/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2022
Is this an Adverse Event Report? No
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
Date Manufacturer Received03/17/2022
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

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