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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL; IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Fracture (1260)
Event Date 12/19/2019
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.
 
Event Description
The manufacturer became aware of a literature published by department of orthopedics, suzhou dushuhu public hospital in china.The title of this report is ¿which implant is better for beginners to learn to treat geriatric intertrochanteric femur fractures: a randomised controlled trial of surgeons, metalwork, and patients¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1016/j.Jot.2019.11.003.This report includes research done on 169 patients between the period january 2011 to february 2017.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 implant breakage for which revision surgery was performed.The report states one implant breakage in the gn-3 group felt sudden pain without any injury at postoperative 11 months (breakage site at the opening for the lag screw).Their common characteristic was the sign of delayed union or nonunion with no evidence of loosening.
 
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Brand Name
UNKNOWN GAMMA3 NAIL
Type of Device
IMPLANT
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 Key11123084
MDR Text Key225264624
Report Number0009610622-2021-00070
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 literature
Reporter Occupation Physician
Type of Report Initial
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/14/2020
Initial Date FDA Received01/06/2021
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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