MAUDE Adverse Event Report: BIOMET ORTHOPEDICS STRAIGHT MONOBLOCK ACETABULAR SHELL INSERTER; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Event date - 2016.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, it states, "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.".

Event Description

It was reported that the thread of the inserter is damaged, chipped.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: unknown acetabular cup, catalog#: ni, lot#: ni.Complaint sample was evaluated and the reported event was confirmed, as the distal threads were found to be fractured.The fracture pattern being consistent with bending overload, evidence of heavy use, and strike marks at the bottom of the handle were noted.Dhr was reviewed and no discrepancies were found.The root cause of the event was unable to be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter and conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: STRAIGHT MONOBLOCK ACETABULAR SHELL 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: 6134616
• MDR Text Key: 61144109
• Report Number: 0001825034-2016-04911
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PK121874
• 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: 03/24/2017

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: 110003450
• Device Lot Number: 636740
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• 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