MAUDE Adverse Event Report: AVITUS ORTHOPAEDICS, INC AVITUS PILOT HOLE DISP - 11 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT/EXTREMITIES

Model Number	N/A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cmp (b)(4) d10: medical products: item#: pc-100, avitus pilot hole disp - 11 mm; lot#: 01234001.H3: product has been received by zimmer biomet and 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 it was time to open the packaging of the product, the packaging had already been opened.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned products identified that the inner blister is not sealed, however there is sealing residue on the blister perimeter indicating that the devices were fully sealed during manufacturing and further tampered with outside of manufacturing.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: AVITUS PILOT HOLE DISP - 11 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT/EXTREMITIES
• Manufacturer (Section D): AVITUS ORTHOPAEDICS, INC; 6 armstrong rd.; suite 107; shelton IL 06484
• Manufacturer (Section G): AVITUS ORTHOPAEDICS, INC.; 6 armstrong rd.; suite 107; shelton CT 06484
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw 46582 ; 5745260384
• MDR Report Key: 20533607
• Report Number: 3011504993-2024-00001
• Device Sequence Number: 20503557
• Product Code: LXH
• UDI-Device Identifier: 00857373006067
• UDI-Public: (01)00857373006067(10)01234001(17)251001
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 11/07/2024

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: 10/01/2025
• Device Model Number: N/A
• Device Catalogue Number: PC-100
• Device Lot Number: 01234001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2024
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Age: 40 YR
• Patient Sex: Male