MAUDE Adverse Event Report: OPTIMIZED ORTHO PTY LTD. CORIN OPTIMIZED POSITIONING SYSTEM; HIP PROSTHESIS

Model Number	1248-1500
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The ops acetabular patient specific guide that was delivered to the surgeon had incorrect orientation.
Additional Manufacturer Narrative
Cc-70 combined report.The ops acetabular guide was used during surgery.The impact to patient cannot be determined as post operative imaging was requested but not provided.There is no evidence that further intervention has been required for this patient.The design history records of the device were retrieved and assessed.It was found that the incorrect orientation was caused by operator error due to manual process.Corrective action is to automate the affected process.Please note: this report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
Additional Manufacturer Narrative
Cc-70 combined report.The ops acetabular guide was used during surgery.The impact to patient cannot be determined as post operative imaging was requested but not provided.There is no evidence that further intervention has been required for this patient.The design history records of the device were retrieved and assessed.It was found that the incorrect orientation was caused by operator error due to manual process.Corrective action is to automate the affected process.Please note: this report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
Event or Problem Description
The ops acetabular patient specific guide that was delivered to the surgeon had incorrect orientation.

• Brand Name: CORIN OPTIMIZED POSITIONING SYSTEM
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): OPTIMIZED ORTHO PTY LTD.; 17 bridge street; pymble, nsw 2073 ; AS 2073
• Manufacturer (Section G): OPTIMIZED ORTHO PTY LTD.; 17 bridge street; pymble, nsw 2073 ; AS 2073
• Manufacturer Contact: martina cecconi ; 17 bridge street; pymble, nsw 2073 ; AS 2073
• MDR Report Key: 7513242
• Report Number: 3012916784-2018-00003
• Device Sequence Number: 7305174
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K152893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1248-1500
• Device Lot Number: DWY_DR_09724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 05/14/2018
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown