MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONFIDENCE KIT, NO NEEDLES; POLYMETHYLMETHACRYLATE BONE CEMENT

Model Number 283913000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 a minimally invasive surgery (mis) surgery was performed at (b)(6) hospital on a (b)(6) year-old female patient suffering from a fraction on her t12 vertebra.During the operation screws were inserted to fix her back from the t10 to l2 vertebra.During the screw-lock stage the surgeon found it difficult to lock the rod connecting the screws along the spine, thus applying a little pressure on the connecting rod and resulting in one of the screws pulling out about 5mm.In order to strengthen the grip of the screws in the vertebrae it was decided to inject cement into all vertebrae using the confidence system.The surgeon injected about 2cc cement in each vertebra (total of 10cc).Several minutes after the cement was injected the anesthesiologist warned that the patient was losing blood pressure and that he was unable to stabilize it.While the surgeon rushed to complete the procedure the patient lost blood pressure and heart rate completely, therefore was flipped on her back without fully closing the area of surgery.After cpr efforts the operating room staff was able to restore the patient's pulse and blood pressure.The patient was sent to intensive care.The patient's neurological condition, blood pressure and pulse measures are normal and the patient's condition is stable.According to the surgeon it is impossible to know what caused the incident and that it is not inevitable that cardiac failure, patient age or anesthetics are the causes of hypotension and discontinuation of the pulse during surgery.It is also unknown what the patient's medical condition was prior to the surgery.Concomitant devices: unknown screws (part #: unknown, lot #: unknown, quantity #: 1); unknown setscrews (part #: unknown, lot #: unknown, quantity #: 1).This report is for one confidence kit, no needles.This is report 1 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: h4: the dhr of product code 283913000, lot 228525, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on (b)(6) 2019.Qty.48.The dhr was electronically reviewed.No relevant nonconformances were observed during dhr review.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

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: h4: manufacturing date updated.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.D6: implant date provided for reporting.E3: reporter's state 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, NO NEEDLES
• 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: 9673242
• MDR Text Key: 190060641
• Report Number: 1526439-2020-00496
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)10705034209630
• 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,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 283913000
• Device Catalogue Number: 283913000
• Device Lot Number: 228525
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN LOCKING/SET SCREWS; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR