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

Model Number N/A

Device Problems Fracture (1260); Difficult or Delayed Separation (4044)

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

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 010002718 name g7 face plate impactor size f lot # zb141101.The product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported inserter bolt for g7 cup became cross threaded in the impactor plate.Upon attempts to remove bolt from plate, ball tip broke off hex driver inside the bolt.All this occurred post procedure and had no impact on surgery.The attempts to remove bolt proved useless and plate is not salvageable.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h4; h6 a g7 ball hex drvr for insr hndl, was returned and evaluated against the complaint.Visual inspection confirmed the 7mm ball hex to be fractured near the tip.The fractured portion was not returned.Sporadic oxidation spots were observed on both the handle and shaft of the driver.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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 event information available at the time of this report.

• Brand Name: G7 BALL HEX DRVR FOR INSR HNDL
• Type of Device: INSTRUMENTS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11449425
• MDR Text Key: 244800566
• Report Number: 0001825034-2021-00695
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• 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: ZB150802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1