MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 8X50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 186731850

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Patient height reported as 160 centimeters.He device history record (dhr) of product code 186731850, lot 253704, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on september 02, 2019.A product investigation was completed: upon visual inspection, it was noticed that the head and shank were received separately.The cap was received in stuck condition with the head.The shank was received in stuck condition with screw remover.The shank was severely damaged, broken, and stripped.The fragments were not received.The devices are in stuck condition, it was not able to be dissembled.The complaint is confirmed since device received in fell apart condition (separated).A definitive root cause could not be determined it is possible that the device encountered unintended forces (during usage or handling at the time of surgery) which may led to complaint condition and jammed condition.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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.

Event Description

It was reported that on (b)(6) 2019, during an unknown procedure, the surgeon was revising an l5-s1 construct by removing the existing hardware.They removed non-depuy hardware from all four (4) pedicles and removed specifically a broken 7.5x50mm screw from the right sides s1 pedicle.When they were inserting a viper cortical fixation 8x50mm screw into the untapped pedicle, the screwdriver broke off in the head of the screw.The surgeon attempted to helicopter the screw out with a custom instrument that had a rod built into it.The head of the screw simply spun in place and eventually broke free.There was a surgical delay of thirty (30) minutes.Fragments were generated and were easily removed.There were no patient consequences.The procedure outcome was unknown.This report is for a viper cortical fixation screw.This is report 1 of 2 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.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: 5.5 TI CORT FIX 8X50MM
• 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: 9520756
• MDR Text Key: 175928299
• Report Number: 1526439-2019-52778
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034352206
• UDI-Public: (01)10705034352206
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186731850
• Device Catalogue Number: 186731850
• Device Lot Number: 253704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 12/31/2019
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 90