MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIVAC NOZZLE SLIM 5PK; ORTHOPEDIC SURGICAL INSTRUMENT

Model Number	N/A
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	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 ¿ foreign ¿ japan.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the sterile package was cut.Attempts have been made and no further information has been provided.This event is related to a malfunction that could potentially lead to a sterility issue/serious injury.However, no patient harm or further outcome was reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h11.Visual examination of provided pictures identified a pouch with a scratch on it.It is not possible to confirm that the pouch is cut with only the picture provided.Visual inspection of the product return show that the carton bow is damaged.The outer packaging is sealed but we can see a cut of around two cm on one side of the package.The other side is not cut.The inner sterile packaging is still intact and not damaged.A review of the device manufacturing records confirmed no abnormalities or deviations that could be review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Reported event did not occur in an operating room or as part of a medical procedure; therefore, no medical records are available for review.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OPTIVAC NOZZLE SLIM 5PK
• Common Device Name: ORTHOPEDIC SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19296847
• Report Number: 3006946279-2024-00025
• Device Sequence Number: 14916803
• Product Code: LXH
• UDI-Device Identifier: 07350023771092
• UDI-Public: (01)07350023771092(17)281231(10)0001815410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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
• Device Model Number: N/A
• Device Catalogue Number: 4154
• Device Lot Number: 0001815410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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
• Patient Sex: Unknown