MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 STR INSRTR THREADED SHAFT; INSTRUMENT, HIP

Catalog Number 110003452

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Concomitant medical products: item # 010002736/ g7 ball hex drvr for insr hndl/ lot # 062100; item # 110010247/ g7 osseoti 4 hole shell 58mm/ lot # unknown; item # 110003451/ g7 str modular shell inserter/ lot # 494810.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2022 -00195, 0001825034 -2022 -00197 and 0001825034 -2022 -00199.

Event Description

It was reported that during a hip procedure the cup insertion handle could not be loosened from cup.Tommy bar was used with g7 ball tip screw driver to try to release cup.G7 ball driver broke at tip and insertion handle was still attached to cup in patient.Whole construct was removed.No adverse events were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual inspection of the returned threaded shaft found wear rings and scratching on the shaft.The large hex feature is dinged and scratched.The lead thread on the tip has been deformed.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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: G7 STR INSRTR THREADED SHAFT
• Type of Device: INSTRUMENT, 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: 13368079
• MDR Text Key: 286362164
• Report Number: 0001825034-2022-00200
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304551602
• UDI-Public: (01)00880304551602(11)201105(10)072082
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110003452
• Device Lot Number: 072082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male