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

Catalog Number	00515004200
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The product has been returned to zimmer biomet.Once the product has been evaluated and the investigation is complete, a follow up/final report will be submitted.G2: foreign - japan.
Event or Problem Description
It was reported that during incoming inspection on (b)(6) 2023, hair like debris was found in the sterile package.There was no patient involvement.No adverse events were reported as a result of this malfunction.Due diligence is complete.No further information is available.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Visual examination of the returned product/provided pictures identified a hair-like particulate within the sealed packaging of one of the products.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.

• Brand Name: DUAL SPIKE Y-CONN. SET, PKG'D
• Common Device Name: 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: 16983157
• Report Number: 0001526350-2023-00491
• Device Sequence Number: 6829039
• Product Code: FQH
• UDI-Device Identifier: 00889024379855
• UDI-Public: (01)00889024379855(17)251110(10)65706371
• 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): 06/30/2023

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 Catalogue Number: 00515004200
• Device Lot Number: 65706371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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: Prefer Not To Disclose