MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIGH CAPACITY NARROW INTRAMEDULLARY TIP; LAVAGE HANDPIECE TIP

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: japan.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: mfr - 0001526350-2023-01184.Mfr - 0001526350-2023-01185.Mfr - 0001526350-2023-01187.Mfr - 0001526350-2023-01188.

Event Description

It was reported that during receiving/inspection that the unit was observed to have debris in the package.There was no harm or injury as there was no patient involvement.Due diligence is complete.No additional information is available.No adverse event reported.

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, h10.Visual examination of the returned product/provided pictures identified there was debris within the sealed packaging.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be 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.Multiple mdr reports were filed for this event, please see associated reports: mfr - 0001526350 - 2023 - 01184-1, mfr - 0001526350 - 2023 - 01185-1, mfr - 0001526350 - 2023 - 01187-1, mfr - 0001526350 - 2023 - 01188-1.

Event Description

No additional information is available regarding the incident.

• Brand Name: HIGH CAPACITY NARROW INTRAMEDULLARY TIP
• Type of Device: LAVAGE HANDPIECE TIP
• 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: 17807034
• MDR Text Key: 324125379
• Report Number: 0001526350-2023-01186
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024374966
• UDI-Public: (01)00889024374966(17)260302(10)65925310
• 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,Followup
• Report Date: 10/02/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00515018200
• Device Lot Number: 65925310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• 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