MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONFIDENCE HYDRAULIC PUMP; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 283906100

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; 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 on an unknown date that the patient was underwent an unknown surgery to stop the cement flow the pressure in the hydraulic pump is reduced by unscrewing the holder.While unscrewing the holder the inner thread got jammed.The inner piston got lifted out which resulted in the liquid to flow out.The inner piston was put back in place and complete the cement augmentation successfully.There were no fragments created.The surgery was delayed two minutes.There was no patient consequence.This is report 4 of 6 (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.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

To stop the cement flow, the pressure in the hydraulic pump is reduced by unscrewing the holder.As the holder was unscrewed the inner thread jammed and the inner piston lifted resulting in the liquid flowing out.The inner piston was put back into place with force and the cement augmentation was completed successfully.There was a surgical delay of twenty (20) minutes.There was no patient harm.

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.H11: b1, b5, h1: the initial complaint was reviewed and found not reportable.It was clarified that there were three (3) devices involved with the complained event, not six (6).The event is captured under manufacturer report numbers 1526439-2020-00452, 1526439-2020-00453, and 1526439-2020-00454.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

The initial complaint was reviewed and found not reportable.It was clarified that there were three (3) devices involved with the complained event, not six (6).The event is captured under manufacturer report numbers 1526439-2020-00452, 1526439-2020-00453, and 1526439-2020-00454.

• Brand Name: CONFIDENCE HYDRAULIC PUMP
• 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: 9629186
• MDR Text Key: 176630525
• Report Number: 1526439-2020-00455
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209562
• UDI-Public: (01)10705034209562
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283906100
• Device Lot Number: 244166
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Patient Sequence Number: 1