MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STRAIGHT MBLOC ACETABULAR SHELL INSERTER; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Fitting Problem (2183)

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

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Complaint sample was evaluated and the reported event was confirmed.Product evaluation showed that the acetabular inserter¿s screw hole was deformed and the handle and its threads had fractured as stated in the complaint.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was most likely fractured from the same mallet blows to the side of the handle as the fracture appears consistent with bending overload.The complaint states that the instrument has been used several times and may have been damaged previously which could have led to the failure in this procedure.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.This report is being submitted late as it has been identified in remediation.

Event Description

The screw hole's threads were deformed after impacting the strike plate with the mallet.This made it not possible to assemble the slap hammer to the inserter.To remove the handle, the surgeon hit the bottom of the handle with the mallet and fractured the handle.In the process, the distal tip of the inserter also fractured.

• Brand Name: STRAIGHT MBLOC ACETABULAR SHELL INSERTER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6997376
• MDR Text Key: 91354751
• Report Number: 0001825034-2017-09858
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110003450
• Device Lot Number: 220810
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1