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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CONDYLE SCREW T2 FEMUR Ø5X75 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL CONDYLE SCREW T2 FEMUR Ø5X75 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1895-5075S
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
The customer reported that "as we have just discussed by telephone, i am sending you an e-mail to inform you of an incident concerning the placement of a retrograde s2 femur nail on monday. Indeed, when the transcondylar screw was placed in compression, it never screwed in despite the 1. 8 pin and the drilling on both sides of the condyle. " additional information received: "the procedure was completed correctly but without this transcondylar compression screw. No clinical consequences to date. Yes, the procedure was delayed by about 20 minutes. No additional medical intervention, but we used the image intensifier more than usual, which could have had repercussions on the patient and the personnel present. ".
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
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Brand NameCONDYLE SCREW T2 FEMUR Ø5X75 MM
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 Key14102939
MDR Text Key289217117
Report Number0009610622-2022-00131
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K014220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1895-5075S
Device Catalogue Number18955075S
Device Lot NumberK027A8F
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? No
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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