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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Visual examination of the provided picture identified that there is damage to the screw threads.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to use error as it was stated that the surgeon deviated from the implantation angle of a screw which caused a collision between two screws.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• 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
• UDI-Device Identifier: 00889024051836
• UDI-Public: (01)00889024051836(11)121011(10)62166452
• 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

1 Patient was 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: Health Professional
• 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
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Male