MAUDE Adverse Event Report: ZIMMER BIOMET, INC. WASHERLOC CORTICAL SCREW 44MM; FASTENER, FIXATION

Model Number 908644

Device Problem Packaging Problem (3007)

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

Event Date 10/27/2022

Event Type  malfunction  

Event Description

It was reported that the clinic did a stock check and found the sleeve inside of sterile pouch was broken or crushed.No adverse event has been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).Concomitant medical products: part:908646, lot:863590, washerloc cortical screw 46mm.Part: 908644 lot: 949280, washerloc cortical screw 44mm.Part: 908644 lot: 949280, washerloc cortical screw 44mm.Report source: japan.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: 0001825034-2022-02463, 0001825034-2022-02464, and 0001825034-2022-02525.

Event Description

Upon visual evaluation of the returned product, it was found that the sterility of the inner pouch has not been breached.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon visual evaluation of the returned product, it was found that the sterility of the inner pouch has not been breached.The initial report was forwarded in error and should be voided.

• Brand Name: WASHERLOC CORTICAL SCREW 44MM
• Type of Device: FASTENER, FIXATION
• 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: 15770853
• MDR Text Key: 307802036
• Report Number: 0001825034-2022-02526
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304410718
• UDI-Public: (01)00880304410718(17)260729(10)949280
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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: 908644
• Device Catalogue Number: 908644
• Device Lot Number: 949280
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 12/22/2022
• Date Device Manufactured: 07/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1