MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME INSERTER SHAFT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 286750031

Device Problem Device-Device Incompatibility (2919)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

Device available for evaluation: 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.Product was not returned.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.(b)(4).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 during a transforaminal lumbar (tlif) procedure on (b)(6) 2019, the scrub nurse had difficulty loading the implant.The surgeon was about to implant but noticed the cage was not straight; the interface with inserter was not straight and in alignment with inserter.Another concorde bullet inserter was tried, but the cage was still not straight.Another implant had to be opened, which loaded correctly.Surgeon was getting s1 nerve root irritation with neuromonitoring so implanted and removed second implant.Had to get ct scan and navigate remaining screws.It was also reported that a viper prime screwdriver was not able to release screw and stylet was bent and had to be cut.There was a surgical delay of ten (10) minutes.Patient is recovering well.Concomitant devices: screws (part: unknown, lot: unknown, quantity: unknown).This report is for a viper prime inserter shaft.This is report 4 of 6 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.H11: corrected data: g4: awareness date reported on follow up 2 report as (b)(6) 2019 but should have been (b)(6) 2020.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.: 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

H10 additional narrative: h3, h6: investigation summary investigation flow: device interaction/functional visual inspection: a viper prime inserter assembly was returned to us cq, all four of its main components were returned assembled to one another.The assembly consisted of: viper prime inserter carrier (part # 286750033 / lot # mf4283703), viper prime insert drive tube (part # 286750034 / lot # unk), viper prime inserter handle (part # 286750032, lot # mf4292702) and viper prime inserter shaft (part # 286750031, lot # mf4302702).The prime stylet depth adjustor and viper prime stylet were also received assembled into the inserter assembly.There was no damage evident on the exterior of the device except one of the set screws appeared to have migrated outward and did not sit flush with the shaft component.The set screw was jammed in its most loose position.Functional test: in its assembled state, the shaft was slightly loose due to one of the screws remaining in its most loose position.It cannot be further tightened.When rotating the handle, the stylet was successfully withdrawn or extended.Functional testing of the shaft collar could not be performed since the relevant mating screw was not returned.The inserter assembly was successfully disassembled by loosening the set screw, and then separating the individual components.Each component was successfully disassembled from one another thus the overall complaint was not confirmed.There was no evidence of a device disassembly issue.Can the complaint be replicated with the returned device(s)? no; device disassembled successfully.The collar could not be tested since the relevant mating screw was not returned.Dimensional inspection: dimensional inspection was not performed as the reported condition could not be confirmed and no damage could be identified that would contribute to the complaint condition.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).Conclusion: the overall complaint was not confirmed for the received viper prime inserter shaft as the device was successfully disassembled.The interaction between the collar and screw could not be tested due to a lack of relevant mating devices.Although no definitive root-cause can be determined it¿s possible the set-screw experienced unintended forces such as over-torque which caused the screw to cross-thread and jam in its hole.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 history lot.A review of the receiving inspection (ri) for the viper prime inserter shaft was conducted identifying that lot number mf4302702 was released in a single batch.¿ batch1: lot qty of 57 units were released on may 16, 2018 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.Device history review 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

H10 additional narrative: h3, h4, h6: a viper prime inserter assembly was returned to us cq, all four of its main components were returned assembled to one another.The assembly consisted of: viper prime inserter carrier (part # 286750033 / lot # mf4283703), viper prime insert drive tube (part # 286750034 / lot # unk), viper prime inserter handle (part # 286750032, lot # mf4292702) and viper prime inserter shaft (part # 286750031, lot # mf4302702).The prime stylet depth adjustor and viper prime stylet were also received assembled into the inserter assembly.There was no damage evident on the exterior of the device except one of the set screws appeared to have migrated outward and did not sit flush with the shaft component.The set screw was jammed in its most loose position.In its assembled state, the shaft was slightly loose due to one of the screws remaining in its most loose position.It cannot be further tightened.When rotating the handle, the stylet was successfully withdrawn or extended.Functional testing of the shaft collar could not be performed since the relevant mating screw was not returned.The inserter assembly was successfully disassembled by loosening the set screw, and then separating the individual components.Each component was successfully disassembled from one another thus the overall complaint was not confirmed.There was no evidence of a device disassembly issue.Dimensional inspection was not performed as the reported condition could not be confirmed and no damage could be identified that would contribute to the complaint condition the overall complaint was not confirmed for the received viper prime inserter shaft as the device was successfully disassembled.The interaction between the collar and screw could not be tested due to a lack of relevant mating devices.Although no definitive root-cause can be determined it¿s possible the set-screw experienced unintended forces such as over-torque which caused the screw to cross-thread and jam in its hole.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 history lot a review of the receiving inspection (ri) for the viper prime inserter shaft was conducted identifying that lot number mf4302702 was released in a single batch.¿ batch1: lot were released on 16-may-2018 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.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 SHAFT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9504457
• MDR Text Key: 189060222
• Report Number: 1526439-2019-52748
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034507583
• UDI-Public: (01)10705034507583
• Combination Product (y/n): N
• PMA/PMN Number: K171570
• 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,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286750031
• Device Catalogue Number: 286750031
• Device Lot Number: MF4302702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS.
• Patient Outcome(s): Required Intervention