MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN RH 125 DEG 11MM X 400MM PROSTHESIS, TRAUMA

Catalog Number 814311400

Device Problem Mechanical Jam (2983)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03170. Concomitant medical products: item# 211201202; lot# unk. Item# 211201200; lot# unk. Report source: foreign - event occurred in (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. 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 surgeon completed a hip fracture nailing operation using the affixus hfn. At the end of the procedure, the jig connecting bolt was unable to be removed from the nail. They ended up using two trays and the handle of insertion jig instrument broke. In the end they had to remove the whole prosthesis and open a third set and new nail to complete the surgery. There was a delay in the procedure of an unknown time. Attempts have been made and no further information has been provided.

• Brand Name: HFN RH 125 DEG 11MM X 400MM
• Type of Device: PROSTHESIS, TRAUMA
• 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: 12844258
• MDR Text Key: 281016743
• Report Number: 0001825034-2021-03169
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K100238
• 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
• Report Date: 04/12/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 814311400
• Device Lot Number: 014900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI