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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN SHORT GAMMA3 NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN SHORT GAMMA3 NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Unintended Movement (3026)
Patient Problems Impaired Healing (2378); Implant Pain (4561)
Event Date 01/06/2018
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 literature published by gothenburg university, in sweden. The title of this report is ¿trochanteric fracture-implant motion during healing ¿ a radiostereometry (rsa) study¿ which is associated with the stryker ¿gamma3 nailing¿ system. The article can be found at https://doi. Org/10. 1016/j. Injury. 2018. 01. 005. Within that publication which included 20 patients, post-operative complications were reported. It was not possible to ascertain specific device details or patient information 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 delayed union accompanied with pain. The report states: ¿clinical fracture healing was defined as absence of pain at the fracture site on weight-bearing. The patient presenting with pain on weight-bearing at 6 months postoperatively eventually healed at 12 months. In this case, postoperative radiographs analysis revealed that the set-screw had not been properly engaged into the lag screw. ¿ as a consequence, this allowed an excessive movement of the fracture-implant system leading to uncontrolled lag screw sliding and exaggerated rotations of the lag screw and femoral head.
 
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Brand NameUNKNOWN SHORT GAMMA3 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 Key11012648
MDR Text Key222026856
Report Number0009610622-2020-00974
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
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 Received11/18/2020
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: 12/15/2020 Patient Sequence Number: 1
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