MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 8X40MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 186727840

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/18/2022

Event Type  Injury  

Event Description

It was reported that during a procedure on (b)(6) 2022, while placing the left side s1 pedicle screw the distal tip of the screwdriver broke off in the head of the screw.The surgeon attempted to remove it and broke the tulip off the shank of the screw.The screw needed to be burred down using a metal cutting burr.The surgery was completed successfully with a delay of 60 minutes.There was no reported adverse patient impact.This report is for a viper system fenestrated cortical fix polyaxial screw 5.5 x 8 x 40mm.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.Additional procode: pml.Device available for evaluation: 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.

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.H3, h6: the device has been 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.

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: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.A review of the receiving inspection (ri) for 5.5 ti cort fix 8x40mm was conducted identifying that lot number avlbf8 released in four batches.Batch1: lot qty of (b)(4) units were released on 04 oct 2016 with no discrepancies.Batch2: lot qty of (b)(4) units were released on 29 sep 2016 with no discrepancies.Batch3: lot qty of (b)(4) units were released on 28 sep 2016 with no discrepancies.Batch4: lot qty of (b)(4) units were released on 23 sep 2016 with no discrepancies.Supplier: (b)(4).The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the 5.5 ti cort fix 8x40mm had the flex ball broken in half, only the head of the screw and one fragment of the ball were returned, the cap and the shank are missing.Embedded device condition cannot be confirmed since x-ray evidence was not provided.A dimensional inspection for the 5.5 ti cort fix 8x40mm was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 5.5 ti cort fix 8x40mm would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 TI CORT FIX 8X40MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15224004
• MDR Text Key: 297872763
• Report Number: 1526439-2022-01393
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034352183
• UDI-Public: (01)10705034352183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186727840
• Device Catalogue Number: 186731840
• Device Lot Number: AVLBF8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 10/11/2022; 10/27/2022
• Supplement Dates FDA Received: 10/24/2022; 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 VIPER UNIV POLY DRIVER
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 171 KG