MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 6X50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 186731650

Device Problem Device Slipped (1584)

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

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent for a plif (posterior lumbar interbody fusion) at l4 left surgery.During the surgery, when surgeon was tightening the screw, screw was felt much tightness.The screw was not situated evenly.Surgeon removed the screw and found some loose area in the screwhead.The procedure was completed with 30 minutes delay.There were no patient consequences reported.Concomitant device reported: unknown tightener (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is for (1) 5.5 ti cort fix 6x50mm.This report is 1 of 1 for (b)(6).

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.The dhr of product code: 186731650.Lot : ardblr.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: march 25, 2014 the product was returned to depuy synthes for evaluation.The product was received at us customer quality (cq).Depuy synthes conducted a visual inspection and a functional assessment of the returned product.Visual analysis of the returned 5.5 ti cort fix 6x50mm revealed that the cap component of the assembly has loosened and does not seat properly in the screw head.The cap sits approximately.25mm above its intended mating point, and is partially rotated such that the cap¿s swaged feature is visible.Functional testing was performed with the assembly.Due to the loose condition of the cap, the screw was able to toggle along its vertical axis due to the gap created between the screw¿s head and the cap.The caps loosening was consistent with excessive force being exerted onto the screw assembly causing the swage to fail.The cap has effectively popped out of place.All relevant measurements were measured and found conforming.The failure was able to be replicated, the complaint was confirmed.It should be noted that as part of depuy synthes¿s quality process all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the received 5.5 ti cort fix 6x50mm.The evaluation determined that the cause of the loosening was due to a failure of the swaged feature of the device.It¿s possible that the screw experienced unintended/overt forces.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.Specified dimensions: screw cap outer diameter = 7.487mm + 0.00mm / - 0.051mm.Screw cap inner diameter = 4.5mm +/- 0.05mm.Screw head inner diameter =7.55mm + / - 0.015mm.Measured dimensions: screw cap outer diameter = 7.484 [measured with om141p].Screw cap inner diameter = 4.53 [measured with gp32].Screw head inner diameter =7.56mm [measured with ca215p].Document/specification review: drawing(s) reviewed: (current & manufactured revisions).Screw cap.Screw head.Screw assembly.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 6X50MM
• 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: 11060005
• MDR Text Key: 229530751
• Report Number: 1526439-2020-02462
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034351841
• UDI-Public: 10705034351841
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186731650
• Device Catalogue Number: 186731650
• Device Lot Number: ARDBLR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 01/13/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWDRIVERS