MAUDE Adverse Event Report: GLOBAL MANUFACTURING TECHNOLOGY PTY LTD PARAGON HIP STEM; PARAGON BROACH - MALE SIZE 05, PRODUCT CODE: LZO

Catalog Number GM08001-331-05

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

Male connection on paragon broach broke in use in the patient, which resulted in greater than 20 minutes surgical delay.

Manufacturer Narrative

Repetitive use of calcar reamer caused weak points around the spigot of the broach resulting in breakage of the spigot during use.As a result of this, paragon broaches from the location of event will be swapped out with brand new sets of broaches.A corrective and preventive action (capa) has been raised by the manufacturer to address this issue and prevent recurrence.Please note: the submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to the event.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.

• Brand Name: PARAGON HIP STEM
• Type of Device: PARAGON BROACH - MALE SIZE 05, PRODUCT CODE: LZO
• Manufacturer (Section D): GLOBAL MANUFACTURING TECHNOLOGY PTY LTD; 17 bridge street; pymble, new south wales 2073 ; AS 2073
• Manufacturer (Section G): GLOBAL MANUFACTURING TECHNOLOGY PTY LTD; 17 bridge street; pymble, new south wales 2073 ; AS 2073
• Manufacturer Contact: robert clemente ; 17 bridge street; pymble, new south wales 2073 ; AS 2073
• MDR Report Key: 12914362
• MDR Text Key: 288857538
• Report Number: 3004537778-2021-00004
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 12/01/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: GM08001-331-05
• Device Lot Number: J17-181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2021
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male