MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 BALL HEX DRVR FOR INSR HNDL; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

It was reported that the tip of the hex driver was broken off while trying to unscrew the cup from the handle.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d4; d9; g3; h2; h3; h4; h6 visual examination of the returned product identified there is some scuffing on the handle and the tip of the device had fractured.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot 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.

Event Description

No further information at the time of this report.

• Brand Name: G7 BALL HEX DRVR FOR INSR HNDL
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17699158
• MDR Text Key: 322844177
• Report Number: 0001825034-2023-02079
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304926820
• UDI-Public: (01)00880304926820(11)190508(10)062100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• 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: 010002736
• Device Lot Number: 062100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1