MAUDE Adverse Event Report: BIOMET ORTHOPEDICS STRAIGHT RINGLOC BTN LATCH INSERTER; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that this type of event may occur.Under precaution it states, "instrument that have experience use of excessive force are susceptible to fracture'.

Event Description

It was reported that the surgeon experienced difficulty implanting the shell into the acetabulum.During impaction, the threaded tip of the handle fractured into the acetabular cup.The cup was removed and another cup was used to complete the procedure.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed signs of repeated use over field service lifetime.Visual inspection was conducted on the returned parts and it was confirmed that the threads of the inserter are fractured.Dimensional analysis was performed on the product and the measurements were found to be within specification.Hardness testing was performed on the shaft of the threaded rod and found to be conforming.The product was sent to sem for fracture analysis and material composition.It was identified that the fracture mode is likely an overload fracture with multiple initiation sites.It appeared only 1.5 turns or less of thread were engaged at the time of fracture with a possible secondary fracture may have been occurred.Based on the location of the initiation site and the direction of the propagation of the fracture, it is likely that the surgeon was leveraging on the inserter at the time of fracture.Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event.Root cause of the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: STRAIGHT RINGLOC BTN LATCH INSERTER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6211032
• MDR Text Key: 63476126
• Report Number: 0001825034-2016-05430
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

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
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: S313152
• Device Lot Number: 617230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1