MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	199721640
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code kwp;kwq;mnh;mni;osh.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, a revision surgery was done because the patient had symptoms of back and leg pain and it was necessary more decompression.During surgery was detected that some screws didn¿t had fixation, they were loose.It was only in the beginning of the surgery that surgeon confirm that some screws were loose.It was unknown if the surgery was completed successfully.The patient outcome was unknown.Concomitant device reported: unknown rods (part# unknown, lot# unknown, quantity unknown ).Unknown screws (part# unknown, lot# unknown, quantity unknown).This complaint involves seven (7) devices.This report is for (1) 5.5 exp verse screw 6.0 x 40.This is report 2 of 7 (b)(4).
Additional 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.H3, h4, h6: the device history record (dhr) of product code: 199721640, lot: 226103, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on december 04, 2018.H3, h6: a product investigation was completed: visual inspection of the complaint device showed the head of the screw was able to rotate.Some black foreign material was by the screw shaft ball and flaking off upon rotation.A functional assessment was performed on the complaint device.The head of the screw was able to rotate.The complaint was not able to be replicated.The relevant drawings were reviewed; no design issues or discrepancies were identified.This complaint is not confirmed as the screw head is able to rotate.However, a foreign substance was observed on the device and flaking off upon rotation.A possible root cause is over-torqueing of the set screws, however no definitive root cause could be identified.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 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: 5.5 EXP VERSE SCREW 6.0 X 40
• Common Device Name: 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: 10535688
• Report Number: 1526439-2020-01689
• Device Sequence Number: 3735385
• Product Code: NKB
• UDI-Device Identifier: 10705034442280
• UDI-Public: 10705034442280
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 199721640
• Device Catalogue Number: 199721640
• Device Lot Number: 226103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 11/13/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 EXP VERSE SCREW 6.0 X 45.; UNKNOWN RODS.; UNKNOWN SCREWS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR