MAUDE Adverse Event Report: . 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD SCREW, FIXATION

Model Number 47-2484-040-50

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Non-union Bone Fracture (2369)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). Report source: foreign: (b)(6). Concomitant products: cmn femoral nail, ccd 130â°, right, 㸠11. 5 mm, 21. 5 cm cat: 47249321211 lot: 3049030; znnâ¿¢, cmn lag screw, 㸠10. 5 mm, 110 mm including set screw cat: 47248511010 lot: 3042384. 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. Product not returned.

Event Description

It was reported that the patient underwent a right side hip nail insertion due to subtrochanteric bone fracture. It was discovered that the nail had migrated. The patient reported pain and femoral nonunion. There was no reported patient fall or false movement. The patient underwent a revision procedure to place a gtr hook plate and cerclage cable with a femoral allograft. Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): .; 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: 13618189
• MDR Text Key: 286232963
• Report Number: 0001825034-2022-00403
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024094062
• UDI-Public: (01)00889024094062(17)300228(10)64689212
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 47-2484-040-50
• Device Catalogue Number: 47248404050
• Device Lot Number: 64689212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/28/2022 Patient Sequence Number: 1