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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON 10X360 MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON 10X360 MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1845-1036S
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Injury (2348)
Date of Event 05/24/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device will not be returned since it was discarded according to information received.If additional information becomes available, it will be provided in a supplemental report.Discarded by hospital.
 
Event or Problem Description
As reported: on (b)(6) 2019, primary operation was performed.On (b)(6) 2020, the patient complained of pain but there was no changes found by the x-ray.On (b)(6) 2020, the broken of the nail was confirmed.On (b)(6) 2020, the broken nail was removed and fixed with t2scn long.
 
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Brand Name
RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON 10X360 MM X 125
Common Device Name
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE  D-24232
MDR Report Key10186467
Report Number0009610622-2020-00298
Device Sequence Number909090
Product Code HSB
UDI-Device Identifier04546540412546
UDI-Public04546540412546
Combination Product (Y/N)N
Initial Reporter CountryJP
PMA/510(K) Number
K102992
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model Number1845-1036S
Device Catalogue Number18451036S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/28/2020
Initial Report FDA Received Date06/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age60 YR
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