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

Model Number 199721000

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: 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.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

It was reported that on (b)(6) 2020, while using the expedium verse for a 2 level tlif.Everything was going as planned until the final tightening.As the surgeon tightened there was a click noise that was not the usual torque limiting click.The surgeon used the correction key locking caps.The set screw was spinning freely with the cap attached and fully seated in the drive mechanism.As the screw was backed out metal shards were coming off the screw tulip.This happened multiple times and wasted 6 screws and countless locking caps.The fragments generated were easily removed.X-rays were taken to confirm that no metal fragments remained in the patient.There was a sixty (60) minute surgical delay, the procedure was successfully completed.There was no patient harm/consequence.Concomitant devices reported: final tightener (part number unknown, lot unknown, quantity unknown), rod (part number unknown, lot unknown, quantity unknown), verse correction key (part number 199721000, lot unknown, quantity 5), viper2 final tightener driver (part number 286745550, lot unknown, quantity 1), verse x25 inserter/tightener (part number 299704230, lot unknown, quantity 2).This report involves one (1) verse correction key.This is report 6 of 9 for (b)(4).This product complaint, (b)(4), is related to (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: d4: lot number.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 noted that two final tighteners were used.The expedium torque handle was used with the viper 2 torque driver and the verse tightener was used with the torque limiting handle.

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.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.H3, h4, h6: the verse correction key (p/n: 199721000, lot number: 277745) was received at us cq.Visual inspection of the complaint device showed that the threads of the correction key were broken.The broken components were not returned.Additionally, the discoloration of the verse correction key was also observed.No other issues were identified.This complaint can be confirmed for verse correction key (p/n: 199721000, lot number: 277745).No definitive root cause can be established.However, the potential cause for the broken threads could be due to the application of unintended forces on the device.There was no indication that a design or manufacturing issue contributed to the complaint.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 history lot the dhr of product code: 199721000 lot : 277745 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 26.03.2020.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: 10555380
• MDR Text Key: 207583660
• Report Number: 1526439-2020-01747
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466132
• UDI-Public: (01)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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/04/2020

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: 277745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 09/23/2020; 10/21/2020; 11/02/2020
• Supplement Dates FDA Received: 10/20/2020; 10/26/2020; 11/02/2020
• Patient Sequence Number: 1
• Treatment: TORQUE WRENCH; UNKNOWN RODS; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE X25 INSERTER/TIGHTENER; VERSE X25 INSERTER/TIGHTENER; VIPER2 FINAL TIGHTENER DRIVER; TORQUE WRENCH; UNKNOWN RODS; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE X25 INSERTER/TIGHTENER; VERSE X25 INSERTER/TIGHTENER; VIPER2 FINAL TIGHTENER DRIVER
• Patient Age: 62 YR
• Patient Weight: 91