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 10/11/2023

Event Type  malfunction  

Event Description

It was reported that during surgery, the hex driver broke.There was no known impact or consequences to the patient.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: d4; d9; g3; h2; h3; h4; h6; h8 part # 010002736 from lot 478058 was returned and evaluated against the complaint.The etching on the returned device was verified to match the complaint.Visual inspection found the ball hex feature to be fractured.The ball hex was not returned.The black finish on the grip has been scratched and scuffed away.Discoloration spots are also present on the grip.The shaft is lightly scuffed/scratched.A review of the device history records identified no deviations or anomalies during manufacturing.The event is confirmed via returned product.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 is available 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: 17974793
• MDR Text Key: 326131308
• Report Number: 0001825034-2023-02472
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304926820
• UDI-Public: (01)00880304926820(11)170214(10)478058
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010002736
• Device Lot Number: 478058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• 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