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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 10X360MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X360MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3425-0360S
Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/10/2020
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device was implanted. Only packaging is available.
 
Event Description
As reported: "the physician found plastic powder on the device, when the packaging was opened. " additionally reported: "the physician cleaned powder on the device and used it. " "the sponge [foam of the packaging] was worn. ".
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X360MM 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
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10370513
MDR Text Key203171005
Report Number0009610622-2020-00438
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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 11/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3425-0360S
Device Catalogue Number34250360S
Device Lot NumberK075B9F
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 Received10/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2017
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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