MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET MV 40G - EO; BONE CEMENT : BONE CEMENT

Catalog Number	3122040
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that vial of liquid in cement box was cracked and leaking.It did not happen in surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary = > no device associated with this report was received for examination.According to the information received, ¿it was reported that vile of liquid in cement box was cracked and leaking.It did not happen in surgery." product description:- smartset mv 40g product code:- 3122040 lot no:- 4382793 quantity of manufactured:- 2870 date of manufacturing:- 08-feb-2024 expiry date:- 31-jan-2026 testing could not be completed as the retained samples are no longer available for testing.There was 1 non-conformances on this lot.On review of the applicable ncs none have been identified which would contribute to the complaint event.The samples returned were tested in a temperature and humidity-controlled laboratory (see page 2).Lot: 4382793 dough time: 02 min 53s (spec: 05 min 00s max) mix characteristics: soft.Setting time: 11 min 12s (spec: 09 min to 13 min 30s).The cement mixed and behaved as expected for the product type and met the appropriate control specification (ms-037 master specification: smartset mv) as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot = > product description: - smartset mv 40g product code:- 3122040 lot no:- 4382793 quantity of manufactured: - 2870 date of manufacturing: - 08-feb-2024 expiry date: - 31-jan-2026 device history review = > a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: SMARTSET MV 40G - EO
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CMW MFG & MATERIAL WAREHOUSE; UK
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20735985
• Report Number: 1818910-2024-24184
• Device Sequence Number: 8287410
• Product Code: LOD
• UDI-Device Identifier: 10603295168379
• UDI-Public: (01)10603295168379(17)260131(10)4382793
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K081155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 01/31/2026
• Device Catalogue Number: 3122040
• Device Lot Number: 4382793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2024
• 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: Unknown