MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11CC; CEMENT, BONE, VERTEBROPLASTY

Model Number 283910000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.The instrument(s) was not returned, and instead, the investigation will be done based on the supplied image(s).The image(s) was reviewed, and the complaint condition for broken could be confirmed as the image provided shows the broken tube.As the instrument(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the plastic tubing broke during an unknown surgery.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.This report is for one (1) confidence spinal cement system confidence plus kit spinal cement system 11cc.This is report 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.H10: additional narrative: d4: lot number, d10; h3, h6: a product investigation was completed: visual inspection of the complaint device showed the tube connection end had broken apart.A dimensional inspection was not performed due to post-manufacturing damage.The relevant documents were reviewed; no design issues or discrepancies were identified.This complaint is confirmed as the tube connection end had broken apart.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that 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.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 SPINAL CEMENT SYSTEM CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11CC
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10587330
• MDR Text Key: 208590753
• Report Number: 1526439-2020-01802
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: 10705034209623
• Combination Product (y/n): N
• PMA/PMN Number: K060300
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283910000
• Device Catalogue Number: 283910000
• Device Lot Number: 281781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1