MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW CORTICAL 46MM; PLATE, FIXATION, BONE/TRAUMA

Catalog Number 1402246

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 02/06/2024

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial hip fracture surgery approximately a month and a half ago.Subsequently, approximately three (3) weeks later the patient reported to the surgeon that they were experiencing pain.Upon undergoing x-rays it was revealed that the distal screws had fractured and were causing the patient pain.The patient will undergo a revision surgery on an unknown date.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00841.D10: medical products: item#: 1402244, bone screw cortical 44mm; lot#: 1402244.G2: foreign: zambia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: BONE SCREW CORTICAL 46MM
• Type of Device: PLATE, FIXATION, BONE/TRAUMA
• 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: 18977893
• MDR Text Key: 338588089
• Report Number: 0001825034-2024-00842
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: K833865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1402246
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention