MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CH CONFIDENCE KIT (7CC); ORTHOPAEDIC CEMENT PREPARATION/DELIVERY KIT

Catalog Number 283907000

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 03/23/2022

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: it was reported by the customer in (b)(6) that during a spinal procedure on (b)(6) 2022 using the orthopaedic cement device kit, it was observed that some sterile water leaked from the hydraulic pump connection despite the fact that the cement was correctly mixed in the initial phase.According to the report, the event occurred during the injection in the final phase of the surgical procedure.There was a delay of 10 minutes.There were no adverse patient consequences reported.No additional information was provided.This report is for one (1) device.

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation was performed on product code: 283907000 with lot number: 326213; and no non-conformances / manufacturing irregularities were identified during the manufacturing process.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONFIDENCE KIT (7CC)
• Type of Device: ORTHOPAEDIC CEMENT PREPARATION/DELIVERY KIT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14222628
• MDR Text Key: 291860826
• Report Number: 1526439-2022-00623
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283907000
• Device Lot Number: 326213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR