MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X30 ST; SCREW, FIXATION

Catalog Number 180553

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported patient has been indicated for revision due to unknown reasons.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: a2, a3, b1, b3, b5, d1, d2, d4, d6, g3, h1, h6, h10 the reported event of screw breaking after a fall on shoulder is not considered a serious injury as it is not device related.This event will be considered not reportable.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

It was reported that the patient is being considered for a revision due to fractured screws due to a fall.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COMP LK SCR 3.5HEX 4.75X30 ST
• Type of Device: SCREW, FIXATION
• 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: 18612776
• MDR Text Key: 334146736
• Report Number: 0001825034-2024-00217
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304818934
• UDI-Public: (01)00880304818934(17)220823(10)614310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130390
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2022
• Device Catalogue Number: 180553
• Device Lot Number: 614310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 83 KG