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 Code Available (3191)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Additional product code kwp; kwq; mnh; mni; osh.Without a lot number, the device history records review could not be completed as no product was received.(b)(4).The device was received, the investigation is in progress, 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

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent a surgery.During the surgery, the external nuts of the correction key have been tightened to block the polyaxiality of the screw.But three nuts of the correction key have been failed to tighten and come out from the screw head.The procedure was completed successfully with 60 minutes delay.The patient outcome was unknown.Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity unknown ).This complaint involves six (6) devices.This report is for (1) verse correction key.This is report 1 of 6 for (b)(4).

Manufacturer Narrative

Product complaint #(b)(4).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.H3, h4, h6: device history lot the dhr of product code 199721000, lot 277570, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on march 24, 2020.Qty.(b)(4).The dhr was electronically reviewed.H3, h6: investigation summary: background: expedium verse advances screws were placed.The first bar was placed and modelled, on each screw was placed a quick stick tube.United set screws were used for proximal and distal screws, while correction key for remaining screws.The external nuts of the correction key have been tightened to block the poli-axiality of the screw.The nuts of the unitezed set screw have been tightened.Same procedure for the second bar.The nuts of the unitezed screw and of the correction key have been tightened in a dynamometric way.In this phase three nuts of the correction key lost tightness and come out from the screw head with a consequence of a new poli-axiality of the screw.The three nuts were replaced but it was not possible the vertebral correction.Delay in the procedure: one hour.(b)(6) 2020: concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity unknown ).This complaint involves six (6) devices.Investigation flow: damage.Visual inspection: the verse correction key (part #: 199721000, lot #: 277570) was received at us cq.The visual inspection showed one of th.No design issues or discrepancies were identified.Complaint was confirmed.Investigation conclusion: this complaint can be confirmed as broken threads could cause the reported failure.No definitive root cause could be determined.It is possible that excessive rotational force/torque was applied while locking it which led to the reported condition.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.

• 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: 10671914
• MDR Text Key: 211130870
• Report Number: 1526439-2020-01934
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721000
• Device Catalogue Number: 199721000
• Device Lot Number: 277570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Date Manufacturer Received: 10/16/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN MONO/POLYAXIAL SCREWS; UNKNOWN MONO/POLYAXIAL SCREWS; UNKNOWN MONO/POLYAXIAL SCREWS; UNKNOWN SCREWDRIVERS; UNKNOWN SCREWDRIVERS; VERSE CORRECTION KEY; VERSE CORRECTION KEY; UNKNOWN SCREWDRIVERS
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Weight: 55