MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT; LAVAGE, JET

Model Number N/A

Device Problems Battery Problem (2885); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that outside of surgery, during unpacking, black battery debris was found in packaging.There was no patient involvement.Diligence is complete.There is no additional information available.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: a3, b4, b5, g3, g6, h2, h3, h4, h6, h11.No product was returned; visual and dimensional evaluations could not be performed.Pictures were provided that confirmed black debris inside packaging.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to manufacturing process.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.

Event Description

No additional event information available.

• Brand Name: HIP KIT
• 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: 18169792
• MDR Text Key: 328534839
• Report Number: 0001526350-2023-01519
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024375185
• UDI-Public: (01)00889024375185(17)260430(10)69509142
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00515048200
• Device Lot Number: 69509142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2023
• 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