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 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j 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.Investigation summary: photo investigation: the device was not returned.A photo-investigation was performed on the images provided.Upon inspecting the images provided, the device components were observed to be held in an unknown packaging material.The complaint condition cannot be confirmed as the devices are not clearly visible.The complaint condition will be investigated further when additional images and/or the products are returned.The root cause for the reported event cannot be determined from the available information.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 cannot be confirmed during photo investigation.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.Device history lot: product code: 283910000 lot : 298282 the dhr was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 26.01.2021.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 during an unknown procedure, the pressure valve of the confidence spinal cement leaked.This made the box of cement unusable.There was no patient consequence.There is no further information available.This report is for one (1) confidence spinal cmt sys, 11c.This is report 1 of 1 for (b)(4).

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.H10 additional narrative: b5: updated event description h3, h6: 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

Additional event information the event occurred during the intra-op but the broken occurred on the instrument table and did not affect the patient.

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: the dhr of product code: 283910000.Lot : 298282.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: january 27, 2021.Cement number: product code 183901001/batch 9624631.Visual inspection: the confidence spinal cmt sys, 11c was returned and received at us customer quality (cq).Upon visual inspection, it is observed that only the hydraulic pump assembly, the cement mixer and the reservoir were returned.The pump contains sterilized water and the reservoir contained hardened cement.The rectus connector and the hose did not feature any damages.It was noted that there was water present past the plunger.This happens when the failsafe valve is triggered as a result of pressure in the pump.No other issues were observed with the device.Functional test: a functional test of the complaint device was performed at cq taking into consideration that the cement had already hardened in the reservoir.The type 20 rectus connector was firmly engaged with the quick-connect feature of the cement reservoir connection.The hydraulic pump was then used normally to build pressure on the water contained to flow through the hose.It was observed that the water was leaking through an opening on the plastic body at the rectus connector connection.The complaint condition is confirmed.Dimensional inspection: a dimensional inspection was not performed as the internal components of the pump and the connector were inaccessible without destruction of the device.Document/specification review: the following drawings (current and manufactured to) were reviewed: confidence, final packaging assembly.Confidence cement reservoir & mixer kit.Confidence pump assembly.Confidence pump body assembly.Confidence sub-assembly, pump body.Confidence elbow connector v3 body.Ifu confidence spinal cement system - 11cc kit.No design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint is being confirmed for confidence spinal cmt sys, 11c as the device leaked and failed the functional test.While a definitive root cause could not be identified for the reported problem, it is possible that the cement had hardened prematurely in the reservoir hence creating excessive pressure leading to the issue.There was no indication that a design or manufacturing issue contributed to the complaint.There is a possibility the cement may have solidified prematurely due to the manner with which it was stored and other environmental factors that might have an impact on the cement¿s setting time contributing to the leak.The confidence spinal cement system kit¿s instructions for use states that the cement should be stored unopened in its original packaging, in a dry, clean place away from light, at a maximum temperature between 41° f (5° c) and 77° f (25° c).Working time at operating room and material temperature of 20 degrees celsius is 9 minutes.The handling characteristics and setting time can vary if the product has not been fully equilibrated at 68° f (20° c) before use.The unopened product should be stored at 68° f (20° c) for a minimum of 24 hours before use.No other potential defects were observed.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.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.D9.E2.H4.

• 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
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12615688
• MDR Text Key: 281429675
• Report Number: 1526439-2021-02140
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: 10705034209623
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• 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: 298282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1