MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME INSERTER HANDLE; ORTHOPAEDIC STEREOTAXIC INSTRU

Model Number 286750032

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

A product investigation was conducted: the instrument(s) was not returned and instead the investigation will be done based on the supplied image(s) from the attachments.The movie and image(s) were reviewed, and the complaint condition could be confirmed as the movie shows that the device is loose when assembled.The complaint for not being able to load the stylet could not be confirmed as this was not seen on the movie, or the pictures.As the instrument(s) was not returned an as received condition, dimensional inspection, material, or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues, or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending, and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot.A review of the receiving inspection (ri) for viper prime inserter handle was conducted identifying that lot number mf4328001 was released in a single batch.Batch 1: lot qty of (b)(4) units were released on (b)(6) 2018 with no discrepancies.Batch 2: lot qty of (b)(4) units were released on (b)(6) 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.

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).This complaint involves three (3) devices.This report is for (1)viper prime inserter handle.This is report 1 of 2 for (b)(4).

Event Description

Concomitant devices: unknown screws (part# unknown, lot# unknown, quantity 3).Unknown hammer /mallet(part# unknown, lot# unknown, quantity unknown ).

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.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

This is report 1 of 4 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: updated data-b5 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.H10 additional narrative: b5: updated.H6: codes updated.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

Only the shaft was replaced.

• Brand Name: VIPER PRIME INSERTER HANDLE
• Type of Device: ORTHOPAEDIC STEREOTAXIC INSTRU
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10734677
• MDR Text Key: 213254769
• Report Number: 1526439-2020-02034
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034507590
• UDI-Public: (01)10705034507590
• Combination Product (y/n): N
• PMA/PMN Number: K170937
• 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
• Report Date: 09/28/2020

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 Number: 286750032
• Device Catalogue Number: 286750032
• Device Lot Number: MF4328001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 11/16/2020; 11/23/2020; 12/08/2020
• Supplement Dates FDA Received: 11/16/2020; 12/04/2020; 12/21/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN HAMMER/MALLET.; UNKNOWN SCREWS.; VIPER PRIME INSERTER CARRIER.
• Patient Age: 48 YR