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

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).G2 foreign: japan.Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that during incoming inspection the product was found to be nonconforming.The product had a foreign substance within the packaging.There was no patient involvement.Diligence is complete.No additional information is available.No adverse events were reported as a result of this malfunction.

• Brand Name: DUAL SPIKE Y-CONN. SET, PKG'D
• Type of Device: LAVAGE, JET
• 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: 18890606
• MDR Text Key: 337518753
• Report Number: 0001526350-2024-00332
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024374928
• UDI-Public: (01)00889024374928(17)260222(10)65925286
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00515004200
• Device Lot Number: 65925286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose