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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER PRIME NAVIGATION INSERTER DRIVE TUBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDOS INTERNATIONAL SàRL CH VIPER PRIME NAVIGATION INSERTER DRIVE TUBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 286750042
Device Problem Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2020, the patient underwent for a surgery.During the surgery, the viper prime navigated driver shaft slightly loosened itself from the driver tube.The stylus not fully going out of the screw as expected (5 mm).The red handle was not turning smoothly (gripped).The stylus was not fully extending outside the screw as expected.Not a problem of loose shaft onto tube.The surgery was completed successfully with 25 minutes delay.There was no patient consequence.Concomitant device reported: viper prime inserter carrier (part# unknown, lot# unknown, quantity 1), unknown screws; (part# unknown, lot# unknown, quantity unknown ); unknown hammer/mallet (part# unknown, lot# unknown, quantity unknown ).This report is for (1) viper prime navigation inserter drive tube.This is report 3 of 4 for (b)(4).
 
Event Description
Only the shaft was replaced.
 
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.H3, h6: the device was received, the investigation is in progress, 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.
 
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.H3, h6: a review of the receiving inspection (ri) for viper prime stylet tool inner was conducted identifying that lot number mf4376208 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 03 jul 2019 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 assembly of viper prime navigated inserter including viper prime inserter handle (part.No: 286750032, lot.No: mf4328001), viper prime inserter carrier (part.No: 286750033, lot.No: mf4344003), prime nav inserter drive tube (part no: 286750042 & lot no: mf4376208) and viper prime nav shaft assy (part no: 286750131n & lot no: mf4283712) was received at us customer quality (cq) in assembled condition.Upon visual inspection at cq, no visual damages were observed on the received devices except normal wear which would not contribute to the reported complaint condition.Functional test: the complete functional testing of the received device was unable to perform as all the mating devices relevant to the complaint condition were not returned at cq.The received viper prime navigator inserter assembly was able to be disassembled and re-assembled as intended with the returned devices.The received prime nav inserter drive tube(part no: 286750042 & lot no: mf4376208) was disassembled and re-assembled with viper prime inserter carrier (part.No: 286750033, lot.No: mf4344003) without any issues.Can the complaint be replicated with the returned devices? unable to perform.Dimensional inspection: the dimensional inspection was not performed since there was no defect identified with the device and received devices were able to be re-assembled as intended.Document/ specification review: the following drawings reflecting the current and manufactured revisions were reviewed during the investigation: viper prime navigation inserter modular drive tube.No design issues or discrepancies were noted during the investigation.Complaint confirmed? no.Investigation conclusion: the complaint cannot be confirmed for the received device as no visual damages were observed on the device and it was able to be disassembled and re-assembled with the mating devices as intended.No definitive root cause could be determined based on the provided information.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.
 
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Brand Name
VIPER PRIME NAVIGATION INSERTER DRIVE TUBE
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key10843250
MDR Text Key216366903
Report Number1526439-2020-02191
Device Sequence Number1
Product Code OLO
UDI-Device Identifier10705034507651
UDI-Public(01)10705034507651
Combination Product (y/n)N
PMA/PMN Number
K170937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number286750042
Device Catalogue Number286750042
Device Lot NumberMF4376208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2020
Initial Date Manufacturer Received 11/11/2020
Initial Date FDA Received11/16/2020
Supplement Dates Manufacturer Received11/23/2020
11/27/2020
Supplement Dates FDA Received12/04/2020
12/21/2020
Patient Sequence Number1
Treatment
PRIME STYLET DEPTH ADJUSTOR.; UNKNOWN HAMMER/MALLET.; UNKNOWN SCREWS.; VIPER PRIME INSERTER CARRIER.; VIPER PRIME INSERTER CARRIER.; VIPER PRIME INSERTER HANDLE.; PRIME STYLET DEPTH ADJUSTOR; UNKNOWN HAMMER/MALLET; UNKNOWN SCREWS; VIPER PRIME INSERTER CARRIER; VIPER PRIME INSERTER CARRIER; VIPER PRIME INSERTER HANDLE
Patient Age48 YR
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