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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR 10X420 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR 10X420 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1825-1042S
Device Problem Material Fragmentation (1261)
Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2021
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The customer reported that : "when a t2 long femur nail was placed, when the nail holder was removed during closure, it was noticed that a "wire" came out of the nail, which was cut flush with the nail. The operators do not know exactly where the wire came from, the ancillary instruments and reamers are intact; they think it is the internal thread of the nail. There were no immediate consequences for the patient, but future removal of the nail may be more difficult if the thread is damaged".
 
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Brand NameFEMORAL NAIL, A/R T2 FEMUR 10X420 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
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11586432
MDR Text Key242972809
Report Number0009610622-2021-00435
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K010801
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1825-1042S
Device Catalogue Number18251042S
Device Lot NumberK075C42
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
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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