MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 199721000

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 on an unknown date that the dual innie set screw thread was shredded and not working properly.There was no reported surgery delay.The surgery was completed successfully.Without additional intervention surgeon was removed all fragments.There was no patient consequence.This is report 04 of 04 of (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.H3, h4, h6: the dhr of product code 199721000, lot 217235, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on september 26, 2018.Qty.(b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition visual inspection: the verse correction key (part # 199721000/ lot # 217235) was received at us customer quality (cq).The threads of the poly lock were stripped.It was also observed that the most distal thread forms of the rod lock were torn.The overall complaint was confirmed as the threads were torn.Device failure/defect identified? yes; threads were torn.Dimensional inspection: dimensional inspection was not performed due to post manufacturing damage.Document/specification review: drawing(s) reviewed: current & manufactured revisions.Conclusion: the overall complaint was confirmed for the received verse correction key as the most proximal threads were torn from the core.Although no definitive root-cause can be determined its possible the device experienced unintended forces while in use.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.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: VERSE CORRECTION KEY
• 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: 9706912
• MDR Text Key: 186023394
• Report Number: 1526439-2020-00536
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466132
• UDI-Public: (01)10705034466132
• Combination Product (y/n): N
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721000
• Device Catalogue Number: 199721000
• Device Lot Number: 217235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Date Manufacturer Received: 04/21/2020
• Patient Sequence Number: 1