MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME INSERTER CARRIER; ORTHOPAEDIC STEREOTAXIC INSTRUMENT

Model Number 286750033

Device Problem Device-Device Incompatibility (2919)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in austria as follows: it was reported that a test phase with the percutaneous stabilization system "viper prime" in combination with the navigation system from brainlab in the context of a patient-specific patient indication was occurring at the (b)(6) / department of neurosurgery.Various orthokits of the navigable viper prime system (instruments and implants) were stationed on site.Instruction of the instruments was conducted on site.Due to the complexity of the navigated viper prime settings, it was also verbally agreed with the users that any operations with this navigable viper prime set of instruments may only be carried out by a surgical assistant or by a representative.Up to (b)(6) 2021, about 2-3 accompanied surgeries of this type were successfully carried out by dr (b)(6) and/or primary (b)(6).A surgery was planned for (b)(6) 2021.No objection to carrying out such surgeries exclusively with a surgical accompaniment from a synthes representative was justified in such a way that the users are sufficiently familiar with this system and that all implants are complete.Dr.(b)(6) on april 14, 2022 reported over the phone about a patient specific case with the percutaneous navigated dorsal spondylodesis supply with the mis system viper prime from (b)(6) 2021.Complications from the (b)(6) 2021 surgery arose in 2022.Dr.(b)(6) described that after defining the navigation data set, he had the navigable viper prime setting instruments fitted with the respective implants by the instrumentalist and two lumbar vertebrae using this navigation data set with the viper prime pedicle screws (screw diameter/length not documented) percutaneously or semi-percutaneously occupied.After implanting all 4 viper prime pedicle screws, dr (b)(6) requested a control scan and found that all implanted screws were shifted by a parallel plane in the image.As dr (b)(6) informed me here, the confirmed misplacement of the pedicle screws damaged neural structures.These four screws were then removed millimeter by millimeter from the vertebral bodies in a time-consuming process.As a result, dr (b)(6) requested the conventional percutaneous navigable "viper2" instruments stationed at (b)(6) regional hospital for control, which he routinely uses.He has a new, up-to-date navigation data record created in advance and references both the navigable "viper2" instrument set (awl, awl) and the navigable viper prime setting instrument set with a viper prime screw.According to dr (b)(6), after locating the anatomical landmark (pedicle entry point) with the navigable viper2 instrumentation (awl, awl), it was accurately depicted on the navigation imaging.As a comparison, he placed the navigable viper prime insertion instrument set referenced with a viper prime screw on the same anatomical landmark (pedicle entry point) and noticed that the screw was again shifted caudally in the navigation imaging.Based on this intraoperative comparison, dr.(b)(6) questioned the accuracy of the viper prime navigable insertion instrument set, arguing that the conventional viper2 navigable instrument set with the identical navigation dataset accurately determines the anatomical landmark (pedicle entry point), while the viper prime navigable instrument set does not match the anatomical landmark ( pedicle entry point) and navigation imaging.Consequently, dr.(b)(6) continued to operate with the navigable viper2 instrument set and fitted two vertebral bodies with 2 expedium cfx screws each (6x40mm).Due to these complications, dr.(b)(6) complains about a considerable delay in the planned operating time.Due to the fact that neither (j&j) nor a representative of brainlab (navigation) accompanied the operation, the description is limited to what dr.(b)(6) said.The surgery was delayed approximately 120 minutes.Actions taken were to remove the viper prime pedicle screws.The procedure was completed successfully.The patient experienced a neuronal disorder; a burning sensation in both feet.This is report 4 of 12 for (b)(4).This report is for a viper inserter.

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.Complainant part is not expected to be returned for manufacturer review/investigation.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.No code available is for neuronal disorder; a burning sensation in both feet.Device history: part # 286750033, lot # mf4249601, supplier: (b)(4).Batch1: lot qty of (b)(4) units were released on 17 july 2017 with no discrepancies.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.Investigation summary.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned samples revealed that the viper prime inserter carrier, p/n: 286750033 exhibits signs of normal use.No significant product problem was observed on the surface of the device.A dimensional inspection was unable to be performed due to the complex geometry of the device.A functional test to assess the reported assembly issues was carried out.Both of the returned viper prime inserter handle, p/n: 286750032, both of the returned viper prime inserter carrier p/n: 286750033, and the returned prime nav inserter drive tube, p/n: 286750042, were used for functional testing.The inserter carrier was introduced inside the inserter drive tube, then both devices were assembled to the inserter handle.After that the shaft assembly was attached.The assembly was secured by tightening both set screws on the shaft assembly.Lastly the returned t handles, p/n: 286750035, were placed on top of the assembly.No significant assembly issue was observed during the functional test.The viper prime inserter carrier, p/n: 286750033 were successfully assembled.The complaint condition was not replicated.An alignment test could not be performed as all the applicable components were not returned.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the the viper prime inserter carrier, p/n: 286750033 would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed: conforms.Dimensional inspection: n/a.Device history: part # 286750033, lot # mf4249601, supplier: (b)(4).¿ batch1: lot qty of (b)(4) units were released on 17 july 2017 with no discrepancies.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: VIPER PRIME INSERTER CARRIER
• Type of Device: ORTHOPAEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14378046
• MDR Text Key: 300073931
• Report Number: 1526439-2022-00703
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034507606
• UDI-Public: (01)10705034507606
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K170937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286750033
• Device Catalogue Number: 286750033
• Device Lot Number: MF4249601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PRIME NAV INSERTER DRIVE TUBE; PRIME STYLET DEPTH ADJUSTOR; VIPER PRIME BRAINLAB ADAPTOR; VIPER PRIME INSERTER HANDLE; VIPER PRIME NAV SHAFT ASSY; VIPER PRIME NAVIGATION STYLET; VIPER PRIME T-HANDLE
• Patient Outcome(s): Required Intervention