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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN 11X340MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN 11X340MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1826-1134S
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2021
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
The physician found plastic powder on the device at opening of the packaging. According to the physician, the plastic powder seemed to be the wear powder of a sponge pad. The device was used for the procedure after washing it with saline.
 
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Brand NameSUPRACONDYLAR NAIL T2 SCN 11X340MM
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
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11812528
MDR Text Key253214925
Report Number0009610622-2021-00512
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
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 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1826-1134S
Device Catalogue Number18261134S
Device Lot NumberK0284F3RA
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 Received09/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2013
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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