MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 40MM 6MM CANCELLOUS SCREW; FASTENER, FIXATION/SPORTS MEDICINE

Model Number	908840
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded at the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that when the implant was removed from the package there was a rip causing the implant to fall on the ground.Therefore, the product was not used.There was no harm to the patient reported.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6.The following sections was corrected: h6 - health impact code.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.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
No further event information available at the time of this report.

• Brand Name: 40MM 6MM CANCELLOUS SCREW
• Common Device Name: FASTENER, FIXATION/SPORTS MEDICINE
• 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: 15197956
• Report Number: 0001825034-2022-01814
• Device Sequence Number: 2252724
• Product Code: MBI
• UDI-Device Identifier: 00880304411104
• UDI-Public: (01)00880304411104(17)260811(10)949390
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2026
• Device Model Number: 908840
• Device Catalogue Number: 908840
• Device Lot Number: 949390
• Was Device Available for Evaluation?: No
• 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: 07/19/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• 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: Male