MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN LAG SCREW 10.5MM X 105MM PROSTHESIS, TRAUMA

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Non-union Bone Fracture (2369); Osteopenia/ Osteoporosis (2651)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

Cmp (b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00014 delano lag screw item #: 814510105 lot #: ug1111305d delano a/r screw item #: 814501090 lot #: dnccm1 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 patient underwent revision approximately four (4) months ago post implantation due to non-union of the fracture and fracturing of the nail and lag screw. It was reported approximately three (3) weeks ago patient underwent revision. During procedure, components were removed and replaced.

• Brand Name: HFN LAG SCREW 10.5MM X 105MM
• 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: 11125266
• MDR Text Key: 225342787
• Report Number: 0001825034-2021-00015
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 814510105
• Device Lot Number: UG1111305D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 01/06/2021 Patient Sequence Number: 1

Treatment

SEE NARRATIVE IN H10