MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME STYLET; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 286750200S

Device Problems Break (1069); Entrapment of Device (1212); Material Twisted/Bent (2981)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

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 as no product was received.The investigation could not be completed, no product was received; 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during the surgery the stylet was broke on patient bone.The surgeon was used alternate instruments to complete the surgery.The surgery was completed successfully with 10 minutes.All generated fragments are still in l3 left pedicle.There were no patient consequences.This complaint involves two (2) device.This is report 1 of 2 for (b)(4).

Event Description

Concomitant devices reported: conf intro ndle, dia, 11g 6", (part number 283903611, lot 244046, quantity 1), viper prime insert drive tube, (part number 286750034, lot unknown, quantity 2).Viper prime inserter carrier, (part number 286750033, lot unknown, quantity 2).Viper prime inserter handle, (part number 286750032, lot unknown, quantity 2).Prime stylet depth adjustor, (part number 286750041, lot unknown, quantity 2).Viper prime inserter shaft, (part number 286750031, lot unknown, quantity 2).Viper prime cfxfen xtab 7x45mm, (part number 186770445, lot tbaafw, quantity 1).

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: h11 corrected data: d11: therapy date should be (b)(6) 2020.G1: corrected manufacturer's contact information.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.H10 additional narrative: h6: additional patient code and device codes.H3,h6: product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: VIPER PRIME STYLET
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10080305
• MDR Text Key: 193325257
• Report Number: 1526439-2020-01070
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034507811
• UDI-Public: (01)10705034507811
• 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
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286750200S
• Device Catalogue Number: 286750200S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Patient Sequence Number: 1
• Treatment: "CONF INTRO NDLE, DIA, 11G 6.; PRIME STYLET DEPTH ADJUSTOR.; VIPER PRIME CFXFEN XTAB 7X45MM.; VIPER PRIME INSERT DRIVE TUBE.; VIPER PRIME INSERTER CARRIER.; VIPER PRIME INSERTER HANDLE.; VIPER PRIME INSERTER SHAFT.
• Patient Outcome(s): Required Intervention