MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE NOZZLE 12 INCH LENGTH .25 INCH O.D.; FLEXIBLE NOZZLE, BONE CEMENT ACCESSORY

Model Number	N/A
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign country: japan.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the distributorship found the products to be nonconforming.Their incoming inspection team member found hair like debris in the sterile package.There was no consequences or impact to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: upon receiving additional information of the reported event, it was determined to be not reportable.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report should be voided.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report should be voided.
Additional Manufacturer Narrative
(b)(4).G2: japan.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported by the incoming inspection team with our distributorship that the products were found to be nonconforming.Their incoming inspection team member found hair like debris in the sterile packaging.There was no consequence or impact to the patient.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product found a hair like fiber approximately.75" long in the sealed sterile pouch.No damage to the pouch was noted.This complaint has been confirmed by review of the returned product.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the packaging operator not following the work instructions 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 or Problem Description
No further information at the time of this report.

• Brand Name: FLEXIBLE NOZZLE 12 INCH LENGTH .25 INCH O.D.
• Common Device Name: FLEXIBLE NOZZLE, BONE CEMENT ACCESSORY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16006204
• Report Number: 0001822565-2022-03514
• Device Sequence Number: 12426161
• Product Code: HWE
• UDI-Device Identifier: 00889024379817
• UDI-Public: (01)00889024379817(17)261214(10)65350180
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/17/2023

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: 00506905400
• Device Lot Number: 65350180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 03/27/2023; 04/14/2023; 05/16/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 03/29/2023; 05/10/2023; 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• 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: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown