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

Model Number 286750033

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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 (b)(6) 2020, as the surgeon was advancing the viper prime pedicle screw, the styler advanced was difficult to advance and rotate.The procedure was successfully completed with a similar product.There was no surgical delay.Concomitant device reported: viper prime pedicle screw (part# unknown, lot# unknown, quantity unknown).This report is for one (1) viper prime inserter carrier.This is report 1 of 1 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.H3, h6: investigation summary: as surgeon was advancing viper prime pedicle screw, the stylet advancer was clunky and difficult to advance and rotate.Completed procedure using same like product.The instrument(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed and the complaint condition could not be confirmed as the image provided only shows the instruments and it would not be possible to tell from an image how the device performs.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 carrier was conducted identifying that lot number mf4344003 was released in a single batch.Batch1: lot qty of (b)(4) units were released on mar 27, 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.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

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.

• Brand Name: VIPER PRIME INSERTER CARRIER
• Type of Device: ORTHOPAEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10485466
• MDR Text Key: 206335645
• Report Number: 1526439-2020-01594
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034507606
• UDI-Public: (01)10705034507606
• 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
• Report Date: 08/08/2020

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: 286750033
• Device Catalogue Number: 286750033
• Device Lot Number: MF4344003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: 08/08/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/03/2020; 09/10/2020
• Supplement Dates FDA Received: 09/25/2020; 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRIME STYLET DEPTH ADJUSTOR; VIPER PRIME INSERT DRIVE TUBE; VIPER PRIME INSERTER HANDLE; VIPER PRIME INSERTER SHAFT; VIPER PRIME PEDICLE SCREW