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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 34251380S
Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2021
Event Type  malfunction  
Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
 
Event Description
It was reported: "the doctor was performing an intramedullary gamma nail on the patient's right side. During the impaction of the nail the locking bolt beacon cold welded to the nail and was unable to separate the targeted from the nail. A new targeter tray was opened with another locking bolt as well as a new nail. The procedure was complete without further incident".
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM X 125
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11899085
MDR Text Key260113089
Report Number0009610622-2021-00531
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K034002
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 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number34251380S
Device Lot NumberK056D4A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2020
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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