MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOW PROFILE SCREW 6.5X40MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 103535, ti low profile screw 6.5x40mm, 2016011269.Report source, foreign ¿ events occurred in the (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 00574.

Event Description

It was reported the screws bent upon insertion.The screws were removed and the surgery was completed with other devices.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: 103535, ti low profile screw 6.5x40mm, 2016011269; 124860ha, exc abt std shell ha/pc 060mm, 2568285.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: TI LOW PROFILE SCREW 6.5X40MM
• Type of Device: PROSTHESIS, HIP
• 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: 7263343
• MDR Text Key: 100004343
• Report Number: 0001825034-2018-00575
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK082446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 103535
• Device Lot Number: 3020479
• Other Device ID Number: (01) 05019279340538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2013
• 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 Sequence Number: 1