MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULTRA-DRIVE 9.5 SHORT OSTEOTOM; HIP INSTRUMENT

Model Number N/A

Device Problems Fracture (1260); Material Twisted/Bent (2981)

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

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Products have been received by zimmer biomet and the investigation is in process.Once the investigation have been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01301, 0001825034-2020-01302, 0001825034-2020-01303.

Event Description

It was reported that during a hip procedure, the products bent, twisted and fractured during use.It is unknown if there was any harm or injury sustained by the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was returned and evaluated against the complaint.Multiple devices were returned and visual inspection of one item number 423859 was fractured and blackened.The second item number 423859 was intact but had been blackened with debris in the tip.Item number 423864 had the tip worn and blackened.Item number 423880 was returned with the tip showing damage and discoloration.Item number 807910 was returned fractured into two pieces.Dhr was reviewed and no discrepancies were found.It was determined that the product worked as intended and what is seen to be normal use of product and no problem found.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: ULTRA-DRIVE 9.5 SHORT OSTEOTOM
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9883224
• MDR Text Key: 185117304
• Report Number: 0001825034-2020-01304
• Device Sequence Number: 1
• Product Code: JDX
• UDI-Device Identifier: 0088030400247
• UDI-Public: (01)0088030400247
• Combination Product (y/n): N
• PMA/PMN Number: K031280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• 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: 423880
• Device Lot Number: 537520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1