MAUDE Adverse Event Report: I.T.S. GMBH STRAIGHT PLATE, 4.5MM; STRAIGHT PLATE, 4.5MM, 13-HOLE

Model Number	21103-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient underwent primary surgery on 2015 for a traumatic femur fracture.He was treated with a im femur nail and recovery appeared fine.Three years after, on a visit to his orthopedic surgeon, it was evidenced that the patient had developed a pseudoarthrosis, reason why surgeon opted for a reintervention with the use of the reported implant (21103-13 hole, 4.5, its (b)(4)).The procedure went without complications with removal of the nail, treatment of the pseudoarthrosis, grafting and implant placement.Patient was discharged without complications.Two weeks after the surgery, our rep receives an x-ray image from the surgeon in which a broken plate was visible.Surgeon reports that patient was compliant and no misuse was suspected.When interviewing the patient, it is found that he was not undergoing pt, but was using a walker.
Event or Problem Description
We recieved information from a distributor that a straight plate with article number 21103-13 broke 2 weeks after the surgery.

• Brand Name: STRAIGHT PLATE, 4.5MM
• Common Device Name: STRAIGHT PLATE, 4.5MM, 13-HOLE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzhöhe, 8301 ; AU 8301
• MDR Report Key: 7446070
• Report Number: 3004369035-2018-00006
• Device Sequence Number: 1949491
• Product Code: HRS
• UDI-Device Identifier: 09120034304781
• UDI-Public: 09120034304781
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: K060156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 21103-13
• Device Catalogue Number: 21103-13
• Device Lot Number: 26/F45350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 04/20/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Weight: 73