MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE SPINAL CMT SYS, 11C; POLYMETHYLMETHACRYLATE BONE CEMENT

Model Number 283910000

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.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 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 that on (b)(6) 2021, the patient underwent for a procedure.During the procedure, confidence cement was leaking abnormally.It was unknown if the procedure completed successfully.There was no patient consequence.This complaint involves two (2) devices.This report is for (1) unk plates.This report is 1 of 2 for (b)(4).

Event Description

This report is for one (1) confidence spinal cmt sys, 11c.

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.H6: photo investigation: the product involved in the complaint was not returned for investigation.So, a photo investigation was completed on the images provided in the email.The hydraulic pump in the confidence spinal cement system pictured has a crack on its proximal end where the tubing and purple colored cylinder meets.It is not possible to determine a definitive root cause as to why this issue had happened from the provided information.A manufacturing record evaluation was done, and no non-conformances were detected during manufacturing that could have resulted in this issue.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed based on the image provided.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.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.H3, h4, h6: a device history record (dhr) review was conducted: the dhr of product code: 283910000.Lot : 300203 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 25.02.2021.Qty: 48.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the hydraulic pump along with the cement reservoir adapter of the 11cc confidence kit was returned to cq west chester for investigation.Upon visual inspection, the cement reservoir was found filled with cement and the cement had solidified.The hydraulic pump had a crack at the plastic tubing connecting the hydraulic pump and cement reservoir.There was no water left inside it.The other returned parts including the needle had no defect on them.No other issues were identified on the device.Functional test: the functional test could not be performed as there was no water inside the pump to check for leakage.The complaint condition cannot be replicated.Dimensional inspection: the complaint relevant dimensions cannot be checked because of the device design which would require the destruction of the pump to access the internal components.Document/specification review: according to the date of manufacture, the current and manufactured revision of drawings were reviewed.Conclusion: the plastic tubing connecting the hydraulic pump to the cement reservoir had a crack on its surface.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 CMT SYS, 11C
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12181991
• MDR Text Key: 263464463
• Report Number: 1526439-2021-01422
• 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,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• 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: 300203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Date Manufacturer Received: 08/23/2021
• Patient Sequence Number: 1
• Treatment: HIGH VISC CMW SPINAL CMT, 11CC