MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 46 MM LENGTH PLATE, FIXATION

Catalog Number 00234702046

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Foreign - event occurred in (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not available for return. The investigation is in process. 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 during fixation of a plate, the threads of the screw were damaged due to the angle of implantation causing it to run into another screw. The screw was removed and a new one was used to complete the surgery. Attempts have been made and no further information has been provided.

• Brand Name: CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 46 MM LENGTH
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12917266
• MDR Text Key: 283088006
• Report Number: 0002648920-2021-00432
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 00234702046
• Device Lot Number: 62166452
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2012
• 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