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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 Problems Break (1069); Fracture (1260)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Ambulation Difficulties (2544); Implant Pain (4561)
Event Date 12/17/2014
Event Type  Injury  
Event Description
The manufacturer became aware of a literature published by the ¿orthopaedic department, parc de salut mar, spain¿. The title of this report is ¿salvage for nail breakage in femoral intramedullary nailing¿, published on december 17, 2014, and can be found at http://dx. Doi. Org/10. 1016/j. Injury. 2014. 12. 003. The report is associated with the stryker ¿gamma 3 nailing system ¿and includes an analysis of the clinical data that was collected on 1246 patients. The cases in this study range from january 2003 to december 2012. During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that one (1) patient experienced implant rupture in the proximal nail aperture, which required revision with a dynamic condilar screw. The report states, ¿all these patients presented hip pain, lameness, and serious difficulty in walking during the postoperative period until the diagnosis of implant breakage was made. All of them lacked a consolidation of the fracture focus at 6 months follow-up¿.
 
Manufacturer Narrative
This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿orthopaedic department, parc de salut mar, spain¿. The article can be found at http://dx. Doi. Org/10. 1016/j. Injury. 2014. 12. 003. The reported event of implant rupture, 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's medical history, the event details and the involved device(s) must be available to determine the root cause.    if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly. Device disposition unknown.
 
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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 Key15262409
MDR Text Key298278990
Report Number0009610622-2022-00388
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial
Report Date 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2022
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
Date Manufacturer Received07/26/2022
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: 08/19/2022 Patient Sequence Number: 1
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