MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSADIAL HEAD IMPACTOR

Catalog Number	407297
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported event is confirmed as product was returned.Verified item and lot numbers on the head impactor matches the complaint.Cannot verify tip as it has not been etched.No visual damage to the threads.Dents and dings on strike plate.Verified the right color of the impactor tip.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the impactor tip fractured during an initial shoulder surgery.This fracture occurred when the surgeon impacted the head onto the stem, and no fragments remained in the patient.The correct surgical technique was used and another impactor from a reverse tray was used to complete the surgery successfully.No patient consequences were reported as a result of this malfunction.Attempts have been made, and no further information has been provided.

• Brand Name: VERSADIAL HEAD IMPACTOR
• Common Device Name: IMPACTOR
• 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: 18336338
• Report Number: 0001825034-2023-03004
• Device Sequence Number: 8488811
• Product Code: HWA
• UDI-Device Identifier: 00880304456679
• UDI-Public: (01)00880304456679(11)210423(10)640860
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

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 Catalogue Number: 407297
• Device Lot Number: 640860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• 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: 11/30/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male