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

Model Number 199721000

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: kwp;kwq;mnh;mni;osh.A product investigation was conducted.Investigation flow: damage.Visual inspection: the verse correction key (part # 199721000 / lot # 262467) was received at us cq.The he correction key's external threads were stripped.There were also some light scratches on the distal and proximal faces of the correction key.The received condition was consistent with the complaint condition thus the complaint was confirmed.Device failure/defect identified? yes; external threads were stripped.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.Although no definitive root-cause can be determined its possible the device experienced unintended 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.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) 2020, when surgeon was applying distraction and compression during the end of the adolescent idiopathic scoliosis (ais) correction, he experienced multiple issues with the implant system expedium verse.The single innie inserter stripe.The inner innie of dual innie stripped when applying final tightening force with torque limiting handle.The outer innie inserter stripped when applying final tightening and the torque limiting handle jammed and not releasing any more at correct torque or at all.An inaccuracy was detected during screw insertion with brain lab aero navigation and verse navigated screwdriver.The screw is only inserted over the kirschner wire for verification of the trajectory created initially with navigated drill or navigated finder; intra-op scan showed no obvious screw misplacement.The surgery was completed with no patient harm but delay of ten -fifteen (10-15) minutes.Compression/distraction was applied after complete construct was already fixed.The surgeon opened the relevant inner innies to allow rod gliding.When he tried to lock the inner innie the screwdriver and inner innie striped/got damaged.The surgeon had to replace those damaged double innies with new double innies.No patient consequences reported.Concomitant device reported: unknown k-wires (part# unknown, lot# unknown, quantity unknown.This complaint involves eleven (11) devices.This report is for (1) verse correction key.This is report 1 of 1 for (b)(4).Related product complaint (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.H10 additional narrative: h3, h4, h6: the device history record (dhr) of product code 199721000, lot 262467, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on november 14, 2019.Visual inspection: the verse correction key was received at us customer quality (cq).The correction key's external threads were stripped.There were also some light scratches on the distal and proximal faces of the correction key.The received condition was consistent with the complaint condition thus the complaint was confirmed.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.Although no definitive root-cause can be determined, it is possible the device experienced unintended 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.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 DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10416023
• MDR Text Key: 204002673
• Report Number: 1526439-2020-01486
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466132
• UDI-Public: 10705034466132
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• 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: 262467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Date Manufacturer Received: 08/20/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE/COMPRESSION/K-WIRES