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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 - 03533, 0001822565 - 2020 - 03539.

Event Description

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

Event Description

Upon receipt of additional information, it has been determined that this device sterility has not been breached.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

(b)(4).Upon receipt of additional information, it has been determined that this device sterility has not been breached.The initial report was forwarded in error and should be voided.Visual evaluation of the returned products confirmed the presence of a crease in the seal of pouche.However, there is no open path or channel through the seal.Sterility was not breached.No other damage was noted.Therefore, the products are acceptable per zimmer biomet acceptance criteria [sterility of the pouch is not compromised].

• 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: 10683584
• MDR Text Key: 211483272
• Report Number: 0001822565-2020-03537
• Device Sequence Number: 1
• Product Code: JDZ
• UDI-Device Identifier: 00889024376584
• UDI-Public: (01)00889024376584(17)250131(10)64633893
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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: 64633893
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1