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

Model Number	908644
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, it was found that the sleeve inside of the sterile pouch has already been crushed or broken.No adverse event has been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).Report source: foreign- 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.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 or Problem Description
Upon receipt of additional information, it has been determined that the sterility of the packaging has not been breached.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that the sterility of the packaging has not been breached.The initial report was forwarded in error and should be voided.

• Brand Name: WASHERLOC CORTICAL SCREW 44MM
• Common Device Name: 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: 15784338
• Report Number: 0001825034-2022-02569
• Device Sequence Number: 3009902
• Product Code: MBI
• UDI-Device Identifier: 00880304410718
• UDI-Public: (01)00880304410718(17)260729(10)949280
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2026
• Device Model Number: 908644
• Device Catalogue Number: 908644
• Device Lot Number: 949280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 12/14/2022
• Date Device Manufactured: 07/29/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown