MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CORTICAL FIX X-TAB 7X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 186770145

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be 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 (b)(6).The patient underwent for a posterior fusion surgery.During the surgery, the screw was being inserted on the l5 right robust bone, the core of the screw got stripped.The procedure was completed without surgical delay.The patient outcome was unknown.No further information is available.This complaint involves two (2) devices.This report is for (1) cortical fix x-tab 7x45 mm ti.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Product complaint #: (b)(4).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 the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that cortical fix x-tab 7x45mm ti the screw was stripped, and no other issues were identified.The dimensional inspection was not performed due to the post manufacturing damage.The observed condition of cortical fix x-tab 7x45mm ti in the device was consistent.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for cortical fix x-tab 7x45mm ti.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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 history lot a review of the receiving inspection (ri) for cortical fix x-tab 7x45mm ti was conducted identifying that lot number tbadms was released in a single batch.Batch1: lot qty of (b)(4) units were released on 24 jun 2020 with no discrepancies.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.

• Brand Name: CORTICAL FIX X-TAB 7X45MM TI
• 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: 12327566
• MDR Text Key: 266897647
• Report Number: 1526439-2021-01704
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034465791
• UDI-Public: 10705034465791
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

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: 186770145
• Device Catalogue Number: 186770145
• Device Lot Number: TBADMS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/28/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWDRIVERS