MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULTRA DRIVE 5MM HOE; HIP INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(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, 0001825034-2020-01304.
Event or Problem 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.
Additional Manufacturer Narrative
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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: ULTRA DRIVE 5MM HOE
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9883047
• Report Number: 0001825034-2020-01303
• Device Sequence Number: 2897202
• Product Code: JDX
• UDI-Device Identifier: 00880304372979
• UDI-Public: (01)00880304372979
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 423864
• Device Lot Number: 429470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1