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 Device-Device Incompatibility (2919); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 that on (b)(6) 2021, that the patient underwent a primary surgery for degenerative scoliosis of the l2-3-4.The patient was implanted with the expedium verse and six (6) pedicle screws.The rod was placed on the left and fixation was performed using the correction key inserter, three (3) correction keys and hand tightening.The left inner screws were fixated using a derotation maneuver with the rod holder and hand tightening.Next the rod was place on the ride side using hand that fixation with three (3) set screws.The final tightening was performed on the three (3) correction keys and then the inner set screws with the torque limiting handle and counter torque.It was then noticed that the inner set screw on l4 could not be tightened and kept turning.The final tightening of the set screws on the right sided rod was performed and the removal of the correction key on the left l4.This was replaced by a set screw which also could not be tightened.It was discovered that the screwhead was damaged.Finally, all of the set screws and the left rod were removed so the l4 screw could be replaced with a bigger screw.The surgery was completed successfully with a twenty (20) minute surgical delay.Concomitant devices: unknown pedicle screws (part# unknown, lot# unknown, quantity 6).Unknown rod (part# unknown, lot# unknown, quantity unknown).Unknown rod holder (part# unknown, lot# unknown, quantity unknown).Unknown torque limiting handle (part# unknown, lot# unknown, quantity unknown).Unknown counter torque (part# unknown, lot# unknown, quantity unknown).Unknown correction key inserter (part# unknown, lot# unknown, quantity unknown).Unknown tightener (part# unknown, lot# unknown, quantity unknown).Unknown setscrews (part# unknown, lot# unknown, quantity unknown).This report is for one (1) verse correction key.This is report 1 of 2 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.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.

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 device history record (dhr) of product code: 199721000 lot : 225038 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: (b)(6) 2018 visual inspection: the verse correction key was received at us customer quality (cq).Visual inspection of the complaint device showed the correction key has its external thread stripped.Functional test: a functional assessment was not performed with the complaint device due the post manufacturing damage of the device.Dimensional inspection: no dimensional inspection was performed due to post manufacturing damage of the device.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the external thread of the correction key was observed to be stripped.This condition could lead to the reported conditions including the inability of the device to assemble with mating devices.However, the stripped thread observed could be due to the "strong hand tightening." although no root cause could definitively be determined for the reported complaint condition, it is likely the device experienced unintended forces.No new, unique, or different patient harms were identified as a result of this evaluation.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 preventive 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.H4.

• 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: 12059672
• MDR Text Key: 265425962
• Report Number: 1526439-2021-01283
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2021

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: 199721000
• Device Catalogue Number: 199721000
• Device Lot Number: 225038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 07/09/2021; 07/22/2021
• Supplement Dates FDA Received: 07/22/2021; 08/18/2021
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE FEN SCR 6.0X50; UNKNOWN CORRECTION KEY INSERTER; UNKNOWN COUNTER TORQUE; UNKNOWN LOCKING/SET SCREWS; UNKNOWN ROD HOLDER; UNKNOWN RODS; UNKNOWN SCREWS; UNKNOWN TIGHTENER; UNKNOWN TORQUE DEVICES