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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Deformity/ Disfigurement (2360); Non-union Bone Fracture (2369)
Event Date 05/25/2016
Event Type  Injury  
Manufacturer Narrative
This complaint has been generated based on findings discovered during post market surveillance literature review. The alleged event of nonunion and deformity, which required revision, could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author. More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause. If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
 
Event Description
The manufacturer became aware of a literature published by the ¿bg trauma hospital hamburg, germany¿. The title of this report is, ¿an electronically instrumented internal fixator for the assessment of bone healing¿, published on may 25, 2016, which is associated with the stryker ¿gamma 3 nailing system¿. The article can be found at https://doi. Org/10. 1302/2046-3758. 55. 2000611. This report includes an analysis of the clinical data that was collected on 39 patients. During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available. It was reported that 1 patient experienced nonunion and deformity, requiring revision. The report states, ¿a 43-year-old patient was treated with the instrumented internal fixator for a nonunion 12 months after primary osteosynthesis with a gamma nail, followed by a revision four weeks later because of a 20° torsional deformity ¿.
 
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Brand NameUNKNOWN GAMMA 3 NAIL
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 Key14987606
MDR Text Key295702978
Report Number0009610622-2022-00327
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial
Report Date 07/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2022
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
Date Manufacturer Received06/15/2022
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

Patient Treatment Data
Date Received: 07/12/2022 Patient Sequence Number: 1
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