MAUDE Adverse Event Report: DEPUY SPINE INC VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 199721000

Device Problem Material Deformation (2976)

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

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

(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.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.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) 2021, the patient underwent for scoliosis surgery using the expedium verse system.During the final tightening, the inner part of the correction keys kept stripping.The stripped correction keys were removed and replaced with unitized set screws.There was a surgical delay of twenty-five (25) minutes.There were no fragments generated.There were no patient consequences.The procedure was successfully completed.Concomitant device reported.Verse x25 inserter/tightener (part# 299704230, lot# unknown, qty 3).This complaint involves thirteen (13) devices.This report is for (1) verse correction key.This report is 10 of 13 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.A manufacturing record evaluation was performed for the finished device product code: 199721000; lot number: 277522; it was electronically reviewed and no non-conformance's / manufacturing irregularities were identified during the manufacturing process.The product was released on: march 20, 2020.Visual inspection: the verse correction key (part# 199721000, lot# 277522 qty# 1) was returned and received at us customer quality (cq).Upon visual inspection, it is observed that the hexlobe feature of the rod lock component was stripped.No other issues were found with the device.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to post manufacturing damage.Document/specification review: the following drawings (current and manufactured to) were reviewed: expedium verse - dual lock assembly; expedium verse - dual lock rod lock; no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for the verse correction key (part# 199721000, lot# 277522 qty# 1).While a definitive root cause could not be identified for the reported issue from the available information, it is likely that the complaint condition was caused due to the use of the worn inserters to fasten the device.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 upon these results, 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): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13088230
• MDR Text Key: 285047276
• Report Number: 1526439-2021-02634
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466132
• UDI-Public: 10705034466132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 199721000
• Device Catalogue Number: 199721000
• Device Lot Number: 277522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE X25 INSERTER/TIGHTENER; VERSE X25 INSERTER/TIGHTENER; VERSE X25 INSERTER/TIGHTENER
• Patient Age: 15 YR
• Patient Sex: Male