MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULTRA DRIVE TIP EXTENDER; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 423871 ultra drive disk drill, 186730.423836 ultra drive tip extender, 434510.423872 ultra drive disk drill, 112350.423873 ultra drive disk drill, 078290.423874 ultra drive disk drill, 716550.423836 ultra drive tip extender, 123460.

Event Description

It was reported that during a hip arthroplasty the instrument broke.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies 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.

Event Description

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

• Brand Name: ULTRA DRIVE TIP EXTENDER
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8152066
• MDR Text Key: 130049286
• Report Number: 0001825034-2018-11196
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• PMA/PMN Number: K031280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 423838
• Device Lot Number: 688070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1