MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSETGMV ENDURANCE GENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3105040

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 06/02/2023

Event Type  malfunction  

Event Description

It was reported that before the surgery, noted black stains on the outer packaging of the ampoule, after opened the packing(did not use), they found that there was no liquid in the ampoule (as the photo shows).Another device was used to complete the surgery.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, "dirty&missing liquid in ampoule.It was reported that before the surgery, noted black stains on the outer packaging of the ampoule, after opened the packing(did not use), they found that there was no liquid in the ampoule (as the photo shows).Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided." the product was not returned to depuy synthes, however photos were provided for review.See attachment (f9292c84-cc19-4328-a172-86220f5ed2d5.Jpeg).The photo investigation revealed that smartsetgmv endurance gent 40g had evidence of ampule leakage, indicating a packaging damage.Once the product leaves depuy synthes control, it is unknown what environment conditions the packaged products are exposed to during that time.Therefore the suspected cause is traced to transport/storage outside of depuy synthes control.The received condition of the device confirmed the reported allegation.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: manufacturing date: 2021-12-16.Expiry date: 2024-11-30.Quantity: 2790.There was 1 non-conformance on this lot.On review of the applicable ncs none have been identified which would contribute to the complaint event.All qc and microbiology testing met specification.A review of the dhr has confirmed that there were no process issues documented that could contribute to the event described.

• Brand Name: SMARTSETGMV ENDURANCE GENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17567387
• MDR Text Key: 321513377
• Report Number: 1818910-2023-16979
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: OUS - SIMILA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3105040
• Device Lot Number: 3684087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1