MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH HIGH VISC CMW SPINAL CMT, 11CC; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 183901001

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: event occurred on an unknown date in 2020.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 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 on an unknown date, water escaped a confidence kit at the valve.There was no surgical or patient impact.The surgery was completed with another available confidence set.There was no surgical delay reported.This report is for one (1) high visc cmw spinal cmt, 11cc.This is report 3 of 3 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.H10 additional narrative: h3, h4, h6- confidence kit, no needles (part# 183901001, lot# 9354479) was returned and received at us cq.The cement package was not returned at cq.It is observed that just label was returned.No further investigation can be performed to confirm the reported problem.The complaint condition cannot be confirmed for the confidence kit, no needles (part# 183901001, lot# 9354479) as the package was not returned and only label was received at cq.A definitive root cause for the reported problem cannot be determined.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot a review of the receiving inspection (ri) for high visc cmw spinal cmt, 11cc was conducted identifying that lot number 9354479 was released in a single batch.¿ batch1: lot units were released on 03 feb 2020 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: HIGH VISC CMW SPINAL CMT, 11CC
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10787533
• MDR Text Key: 214642338
• Report Number: 1526439-2020-02094
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034455006
• UDI-Public: (01)10705034455006
• Combination Product (y/n): N
• PMA/PMN Number: K112907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 183901001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Date Manufacturer Received: 10/27/2020
• Patient Sequence Number: 1
• Treatment: CONFIDENCE KIT, NO NEEDLES; CONFIDENCE KIT, NO NEEDLES; CONFIDENCE KIT, NO NEEDLES; CONFIDENCE KIT, NO NEEDLES