MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DUAL SPIKE Y-CONN. SET, PKG'D; SURGICAL IRRIGATION SYSTEM NOZZLE

Model Number	N/A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
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 that during inspection, it was found that there was debris in the sterile packaging.There was no patient involvement.Due diligence is complete and there is no additional information available.
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.E1 telephone number: (b)(6).
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under cmp-(b)(4).Following sections were updated or corrected: b4, b5, d2, d4, d9, g1, g3, g6, h1, h2, h3, h4, h6, and h10.Visual examination of the returned product/provided pictures identified one dual spike had residue or a stain on the surface of the tubing for one sealed connector - approximately 2.50 mm sq.(not within the acceptance criteria for 8.400 zpc packaging materials inspection).Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed.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.G2 country: japan multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-00545-1.
Event or Problem Description
There is no additional information available regarding this event.

• Brand Name: DUAL SPIKE Y-CONN. SET, PKG'D
• Common Device Name: SURGICAL IRRIGATION SYSTEM NOZZLE
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17083494
• Report Number: 0001526350-2023-00546
• Device Sequence Number: 6468598
• Product Code: FQH
• UDI-Device Identifier: 00889024379855
• UDI-Public: (01)00889024379855(17)251110(10)65706372
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

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 Expiration Date: 11/10/2025
• Device Model Number: N/A
• Device Catalogue Number: 00515004200
• Device Lot Number: 65706372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Prefer Not To Disclose