MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISPOSABLE MIXING BOWL AND SPATULA; INSTRUMENTS, HIPS

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

It was reported during incoming inspection that wrinkles were found in the sealing area.No known impact or consequence to the patient.

Manufacturer Narrative

(b)(4).D10: 00504901100 disposable mixing bowl and spatula 66330620; g2: foreign: japan; multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 03358; customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Visual evaluation of the returned product found creasing in the seal for (2) pouches.A dye test found the seals are conforming.As the product was determined to be acceptable per review of the inspection criteria, a complaint history review was not performed.No product failure was found as the product is within specifications.No further investigation or action is required after review.This complaint cannot be confirmed as the product was found to be conforming.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 to report at this time.

• Brand Name: DISPOSABLE MIXING BOWL AND SPATULA
• Type of Device: INSTRUMENTS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18226717
• MDR Text Key: 329238142
• Report Number: 0001822565-2023-03359
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 00889024376564
• UDI-Public: (01)00889024376564(17)280924(10)66330620
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: 00504901100
• Device Lot Number: 66330620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE