MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; SCREW, FIXATION, BONE

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/ unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.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.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

It was reported that on (b)(6) 2020, during an unknown procedure, the viper prime inserter shaft came loose from the screw mid-insertion.It was still tight on the tower of the screw but where the inserter shaft meets the shank of the screw came loose, causing the tip of the screw to also be loose and therefore throwing off our navigation projection.The screw was removed from canal and attempted to be placed in pedicle three times.There was a surgical delay of fifteen to thirty (15 to 30) minutes.The patient was very close to having motor or sensory nerve issues due to screw being placed in the spinal canal.Multiple additional screw placements and o-arm spins are required.The procedure was successfully completed.The screw was thrown in the sharps disposables after the case by the hospital.The viper prime inserter shaft was inspected and appeared to be fine.Concomitant device reported: viper prime inserter shaft (part # 286750031, lot # unknown, quantity 1).This report is for one (1) unknown screw.This is report 2 of 2 for complaint (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.The device was not returned.An investigation was performed using the image the image depicted a fluoroscopy view of the surgical site.It was apparent the unknown pedicle screw was not located an appropriate location.No product issues were observed that would have contributed to the complaint condition.No additional issues were observed.No device identifiers were visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The complaint condition was confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.A potential- or root-cause could not be determined from the images provided.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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.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

Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity unknown).

• Brand Name: UNKNOWN SCREWS
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10863998
• MDR Text Key: 217147549
• Report Number: 1526439-2020-02230
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS; VIPER PRIME INSERTER SHAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR