MAUDE Adverse Event Report: NEOORTHO PRODUTOS ORTOPEDICOS S/A NEOFIX; 900.362 - 8-HOLE NARROW 4.5 LS PLATE

Model Number	900.362
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not distributed in the united states of america.It was related that 8-hole narrow 4.5 ls plate was broken after its implantation when the patient gdmr was transferred from the chair to the stretcher when she was going to perform an x-ray exam at the hospital.Identified plate (code: 900.362, description: 8-hole narrow 4.5 ls plate, lot: 3657145, qty: 1).Date of manufacture: 16/oct/2015 and expiration date: 16/oct/2030.No information about the type of surgery or the implantation date of the material.No information about the explanation date of the broken plate.Documents and evidence were requested from the distributor, such as radiographic records (pre-operative, post-operative, follow-up, and failure), a medical report describing the occurrence and patient characteristics regarding this event, but we had no return, so they are unknown.No significant surgical delay or injury to the patient was reported.Dhr of this lot was analyzed with no faults, including raw material.Based on the available information, no corrective and/or preventive action was required.This occurrence generated the need to notify adverse events to anvisa through notification no.(b)(4).This event will be accounted for and monitored through post-market surveillance activities.If additional information becomes available, the investigation will be updated as applicable.
Event or Problem Description
It was related that 8-hole narrow 4.5 ls plate was broken after its implantation when the patient gdmr.Was transferred from the chair to the stretcher when she was going to perform an x-ray exam at the hospital.

• Brand Name: NEOFIX
• Common Device Name: 900.362 - 8-HOLE NARROW 4.5 LS PLATE
• Manufacturer (Section D): NEOORTHO PRODUTOS ORTOPEDICOS S/A; rua angelo domingos durigan; curitiba, parana 82025 100; BR 82025100
• MDR Report Key: 10143757
• Report Number: 3009158523-2020-00001
• Device Sequence Number: 11348457
• Product Code: HRS
• UDI-Device Identifier: 07898624861502
• UDI-Public: 07898624861502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 900.362
• Device Catalogue Number: 900.362
• Device Lot Number: 3657145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR