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

Model Number 1248-0064

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

The ops canister clamp assembly was reported to not tighten and come loose.The issue was identified during the procedure.As a spare ops canister clamp assembly was available, the faulty instruments was replaced and the procedure completed with no impact to the patient or user.The reporter of this event was unable to confirm which case out of two this malfunction was detected in and as such the patient details are reported for the first case of that day; neither case was affected by this issue.This issue was confirmed to not result in an adverse event and/or further intervention for a patient.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 Description

The ops canister clamp assembly was reported to not tighten and come loose.The issue was identified during the procedure.As a spare ops canister clamp assembly was available, the faulty instruments was replaced and the procedure completed with no impact to the patient or user.This issue was confirmed to not result in an adverse event and/or further intervention for a patient.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 Description

The ops canister clamp assembly was reported to not tighten and come loose.The issue was identified during the procedure.As a spare ops canister clamp assembly was available, the faulty instruments was replaced and the procedure completed with no impact to the patient or user.This issue was confirmed to not result in an adverse event and/or further intervention for a patient.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.

Manufacturer Narrative

Method: the device was requested to be returned from the customer.The wrong device was returned to optimized ortho for investigation.Multiple attempts were made to retrieve the complaint device.Upon further inspection, it was found that the complaint device was scrapped at the regional office unintentionally.Results: we were unable to investigate the complaint device as the device was not returned to the manufacturer.However, based on the investigation of previous non-conformances for other lot numbers of the device, it was discovered that the design of the cannister clamp was updated in june 2016.The revised design allowed for better compatability between the clamp and the attachment by expanding the flexibility of the interaction feature.Since then, this type of issue never occurred.The complaint device was manufactured prior to the design change as per the lot number provided.Conclusion: this issue was confirmed to not result in an adverse event and/or further medical intervention for the patient.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.Please note: the submission of this report does not constitute and admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

• Brand Name: CORIN OPTIMIZED POSITIONING SYSTEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): OPTIMIZED ORTHO PTY LTD; 17 bridge street; pymble, nsw 2073 ; AS 2073
• MDR Report Key: 9399513
• MDR Text Key: 193948907
• Report Number: 3012916784-2019-00023
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K152893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1248-0064
• Device Lot Number: AD0196
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/19/2019
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1