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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN 10X360MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN 10X360MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1826-1036S
Device Problem 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 07/02/2020
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.
 
Event Description
As reported: "styrofoam scrapes was in the nail screw holes in a sterile package when the package of the nail was opened during the operation. The procedure continued without exchanging the product after it was cleaned. ".
 
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Brand NameSUPRACONDYLAR NAIL T2 SCN 10X360MM
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 Key10339752
MDR Text Key200852146
Report Number0009610622-2020-00409
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K023267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model Number1826-1036S
Device Catalogue Number18261036S
Device Lot NumberK0AABC6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2015
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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