MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONFIDENCE KIT SPINAL CEMENT SYSTEM 7CC; ORTHOPAEDIC CEMENT PREPARATION/DELIVERY KIT

Catalog Number 283907000

Device Problems Break (1069); Device Difficult to Maintain (3134)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Procode is unknown.Udi: unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.510k: unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that a product specialist reported about problems with the cement's confidence.When cement has been filled up and it mixed, the handle froze in one position.The mechanism broke after 10 turns.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

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.The pump is mostly used, as is the contents of the cement reservoir.However, the cement mixer was returned having its parts seized together due to the cement volume inside.The mixer carries some extra cement weight outside of its own, but it is unknown how much cement is inside.The cement appears to have solidified while still in the mixer.The remaining parts appear to have been used after the original mixer seized.A review of the cement¿s manufacturing records found no issues.There is a possibility the cement may have solidified prematurely due to the manner with which it was stored and other environmental factors that might have an impact on the cement¿s setting time.A review of the device history record for the kit was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A follow-up dhr review was performed on the high viscosity spinal cement that is part of this kit (product code: 1839-01-001, lot number: 9009078).No discrepancies were observed during the manufacturing process.The root cause of the cement setting prematurely cannot be determined from the sample and the information provided.A potential root cause may be environment factors related to the storage of the cement.No corrective and preventive action (capa) is necessary at this time as no issues could be identified in the manufacturing or release of these products.Therefore, this complaint will be closed with no further action required.

• Brand Name: CONFIDENCE KIT SPINAL CEMENT SYSTEM 7CC
• Type of Device: ORTHOPAEDIC CEMENT PREPARATION/DELIVERY KIT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9406411
• MDR Text Key: 185294676
• Report Number: 1526439-2019-52552
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• 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: 235030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Date Manufacturer Received: 02/04/2020
• Patient Sequence Number: 1