MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULTRA DRIVE 7MM DISK DRILL; HIPS, INSTRUMENTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the two instruments broke during surgery.No known impact or consequence to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: 423859 5mm reverse curette 147260.G2: foreign: netherlands.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01253.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, d9, g3, g6, h2, h3, h4, h6 proposed component code mechanical (g04) - drill an ultra drive 7mm disk drill, part # 423871 from lot 600710, was returned and evaluated against the complaint.The packaging lot was confirmed with the complaint.Nicks and scratching are present on the proximal end of the drill near the connection feature.Scratching and scuffing are present on the shaft.The disk drill tip is fractured and was not returned with the remainder of the device.A review of the device history records identified no deviations or anomalies during manufacturing.A review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.Event is confirmed via returned product.If any further information is found 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: ULTRA DRIVE 7MM DISK DRILL
• Common Device Name: HIPS, INSTRUMENTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17038407
• Report Number: 0001825034-2023-01252
• Device Sequence Number: 20557351
• Product Code: JDX
• UDI-Device Identifier: 00880304000452
• UDI-Public: (01)00880304000452(17)310315(10)600710
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K900003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2023

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: 423871
• Device Lot Number: 600710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Sex: Male