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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, STST GAMMA3 10.5X95MM IMPLANT

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STRYKER TRAUMA KIEL LAG SCREW, STST GAMMA3 10.5X95MM IMPLANT Back to Search Results
Catalog Number 40600095S
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device is not cleared for sale in the u. S. , but a similar device is commercially available in the u. S. Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
The customer reported that: "i would like to ask you about a defective 125° short gamma nail. I wanted to insert a short gamma nail this morning for a pertrochanteric fracture. I encountered a problem with the nail locking screw. The cervicocephalic screw was not locking with the proximal locking screw. I mentioned a problem with the cervicocephalic screw. Changing the cervicocephalic screw did not solve the problem. I had to change the 125° short gamma nail, which solved the problem. When testing the nail outside the patient, i found that the locking mechanism of the cervicocephalic screw did not work. I kept the nail in my office in cannes. ".
 
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Brand NameLAG SCREW, STST GAMMA3 10.5X95MM
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
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11262765
MDR Text Key230753447
Report Number0009610622-2021-00255
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number40600095S
Device Lot NumberK0F207E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2020
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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