MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number 199721000S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: a product investigation was conducted.Visual inspection: the 5.5 exp verse di set scr (p/n: (b)(4), lot #: 169335) was returned and received at us cq.Upon visual inspection, it was observed that the distal threads of the set screw components were observed to be stripped.No other issues were identified with the returned device.Functional test: a functional test was not performed as the mating devices were not returned.Stripped threads could have caused the complaint condition.Dimensional inspection: a dimensional inspection was performed on the returned device.The major thread diameter of the set screw was measured and is within the specification per relevant drawing.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed investigation conclusion: the complaint condition was confirmed for the 5.5 exp verse di set scr (p/n: (b)(4), lot #: 169335) as the threads were stripped which could have caused the complaint condition.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.A device history record (dhr) review was conducted: product code: (b)(4).Lot: 169335.It was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on (b)(6) 2017.Qty: 214.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 the spinal fusion procedure to treat the adolescent idiopathic scoliosis in t4-t12.During screw and rod fixations, the surgeon used a quick stick to prevent cross-threading.However, the following events took place.There was uneasiness with the correction key, a replacement was used without further issue.Torque was not able to be applied to the correction key during the final screw fixation.Subsequent to the above-mentioned, item 2, the surgeon used a replacing correction key, but the same resulted and a metal-like object came out of the screwhead.As the final replacement, a unitized setscrew was used but was not able to apply torque again.The setscrew was manually tightened and completed the procedure.There was less than a thirty (30) minute delay.No further information is available.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown).Unknown rod (part# unknown, lot# unknown, quantity unknown).Unknown tightener (part# unknown, lot# unknown, quantity unknown).This report is for one (1) expedium verse spine system verse correction key 5.5.This is report 3 of 3 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.Date received by manufacturer was inadvertently reported as (b)(6) 2020 on initial medwatch report.The correct date should have been (b)(6) 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: EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10556401
• MDR Text Key: 207609847
• Report Number: 1526439-2020-01752
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034466125
• UDI-Public: (01)10705034466125
• 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
• Report Date: 07/20/2020

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 Expiration Date: 11/30/2022
• Device Catalogue Number: 199721000S
• Device Lot Number: 169335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 09/29/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN RODS; UNKNOWN SCREWDRIVERS; UNKNOWN SCREWS; UNKNOWN RODS; UNKNOWN SCREWDRIVERS; UNKNOWN SCREWS
• Patient Age: 14 YR
• Patient Weight: 50