MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIGH CAPACITY 8" INTRAMEDULLARY TIP; LAVAGE, JET

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 11/28/2023

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 at the distributor warehouse a foreign substance was found within the sterile 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.

Event Description

The initial report was forwarded in error and should be voided.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.

• Brand Name: HIGH CAPACITY 8" INTRAMEDULLARY TIP
• 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: 18373863
• MDR Text Key: 331115712
• Report Number: 0001526350-2023-01673
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024374959
• UDI-Public: (01)00889024374959(17)250222(10)65421880
• 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: 01/31/2024

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: 00515018100
• Device Lot Number: 65421880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 01/31/2024
• 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