MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. BIOMET BONE CMENT R 1X40 JP; BONE CEMENT

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 06/06/2023

Event Type  malfunction  

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 Description

It was reported that the customer found the inner cement pouch opened on one side in the corner.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

Upon reassessment of the reported event, it was determined a medwatch report should not have been filed as a breach of the inner seal does not compromise the sterility and safety of the device if the outer pouch is intact.There have been no complaints reported associated with issues of the outer pouch being compromised.The reported event does not meet the definition of a reportable malfunction as there was no patient harm that occurred as a result of this event nor has this event ever led to a serious injury associated with this product failure in the past with same or similar devices.Given this information, this medwatch will be voided.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined a medwatch report should not have been filed as a breach of the inner seal does not compromise the sterility and safety of the device if the outer pouch is intact.There have been no complaints reported associated with issues of the outer pouch being compromised.The reported event does not meet the definition of a reportable malfunction as there was no patient harm that occurred as a result of this event nor has this event ever led to a serious injury associated with this product failure in the past with same or similar devices.Given this information, this medwatch will be voided.

• Brand Name: BIOMET BONE CMENT R 1X40 JP
• Type of Device: BONE CEMENT
• 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: 17296871
• MDR Text Key: 319414150
• Report Number: 3006946279-2023-00064
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00887868358487
• UDI-Public: (01)00887868358487(17)231031(10)X02CAC1701
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• 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: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 110035372
• Device Lot Number: X02CAC1701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1