MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM FENESTRATED SCREW MIS CANNULA 16G X 228MM; DISPENSER, CEMENT

Model Number 279726508

Device Problem Break (1069)

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

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 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 an unknown date that two products were broken.This report is for 1 viper system fenestrated screw mis cannula 16g x 228mm.This is report 2 of 2 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: d9 h3, h6: a review of the receiving inspection (ri) for fen mis cannula was conducted identifying that lot number lc34768 was released in a single batch.¿ batch1: lot qty of 728 units were released on july 9, 2020 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual inspection: the fen mis cannula strl (part# 279726508, lot# lc34768 qty# 1) was returned and received at us customer quality (cq).Upon visual inspection, it is observed that the small tube has broken off the ferrule.The broken piece was also returned.No other issues were noted with the device.Dimensional inspection: major external diameter: conforming.Minor internal diameter: conforming.Caliper.Document/specification review: the following drawings (current and manufactured to) were reviewed: - expedium adult - fenestrated cannula - overmold.- expedium adult - fenestrated cannula sub-assembly.- expedium adult - fenestrated cannula - large tube.- expedium adult - fenestrated cannula - small tube.- expedium adult - fenestrated cannula - ferrule.No design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for the fen mis cannula strl (part# 279726508, lot# lc34768 qty# 1).While a definitive root cause could not be identified for the reported problem, it is possible that the device might have encountered unintended forces.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 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.

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.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: it was reported on an unknown date the patient underwent for a procedure.During the procedure, two products were broken.It was unknown how it was occurred.It was unknown if the surgery completed successfully.The patient outcome was unknown.

• Brand Name: VIPER SYSTEM FENESTRATED SCREW MIS CANNULA 16G X 228MM
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12683312
• MDR Text Key: 277951779
• Report Number: 1526439-2021-02238
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10705034199566
• UDI-Public: 10705034199566
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279726508
• Device Catalogue Number: 279726508
• Device Lot Number: LC34768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FEN MIS CANNULA STRL; FEN MIS CANNULA STRL