MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X25 ST; EXTREMITIES IMPLANTS

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported, that the customer had opened the original sealed box and went to open the screw package, but noticed the screw appears to be melted to the inner packaging.No further information at this time.

Manufacturer Narrative

(b)(4).Reported event was confirmed as visual evaluation of the returned product found the pouch exhibits damage that is visually consistent with thermal damage.Outer pouch visually appears to be adhered to the inner pouch.Sterility has been breached.This complaint has been confirmed by evaluation of the returned product.Device history record was reviewed and no discrepancies relevant to the reported event were found.The condition of the device when it left zimmer biomet is considered non-conforming to specification.The root cause of the reported event can be attributed to packaging operator not following the work instructions provided.Corrective actions have been initiated.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP LK SCR 3.5HEX 4.75X25 ST
• Type of Device: EXTREMITIES IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18168941
• MDR Text Key: 328527742
• Report Number: 0001825034-2023-02634
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304677159
• UDI-Public: (01)00880304677159(17)330722(10)66189988
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• 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: 180552
• Device Lot Number: 66189988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2023
• 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