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

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign: country: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02390, 0001822565 - 2020 - 02391, 0001822565 - 2020 - 02392, 0001822565 - 2020 - 02393, 0001822565 - 2020 - 02394, 0001822565 - 2020 - 02395, 0001822565 - 2020 - 02396, 0001822565 - 2020 - 02397, 0001822565 - 2020 - 02398, 0001822565 - 2020 - 02399, 0001822565 - 2020 - 02401, 0001822565 - 2020 - 02402, 0001822565 - 2020 - 02403, 0001822565 - 2020 - 02404, 0001822565 - 2020 - 02405, 0001822565 - 2020 - 02407.

Event Description

It was reported by the distributorship that the products were found to be nonconforming.No patient involvement.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned products confirmed that 18 out-of-20 contain foreign debris.Sixteen of the 20 sterile pouches contain a loose blue particle.One sterile pouch contains 2 particles.All loose particles exceed the.60 sq.Mm size allowed by zpc 8.400 rev.52, as measured with the tappi chart 25-2007-187-00-ey.One sterile pouch has a hair-like fiber measuring approximately.400 in length.Device history record (dhr) was reviewed and no discrepancies were found.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The likely condition of the parts when they left zimmer biomet control is considered non-conforming based on the evaluation of the returned products.The loose blue particles likely came from the excess flash generated during the molding process of the mixing bowl and/or during the trimming of this excess flash.Although a definitive source of the hair-like fiber cannot be determined, it was introduced during manufacturing because it was located in the sealed pouch.The root cause of the reported issue is attributed to a manufacturing issue.A corrective action has been initiated to address this issue.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.

Event Description

No further event information available at the time of this report.

• Brand Name: DISPOSABLE MIXING BOWL AND SPATULA
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10239919
• MDR Text Key: 198319931
• Report Number: 0001822565-2020-02406
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 00889024376684
• UDI-Public: (01)00889024376684(17)250131(10)64655319
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• 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: 64655319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1