MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 5X45; ORTHOSIS,PEDICLE SPINAL FIXATION

Model Number	186727545
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 as no product was received.The investigation could not be completed, no product was received; 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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent for a surgery.During the surgery, cross threading of screw cap leading to tulip head of screw damage.The surgery was completed successfully with 10 minutes delay.There were no patient consequences reported.Concomitant device reported: unknown setscrews (part# unknown, lot# unknown, quantity unknown).Unknown rods (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) mis ti cfx fen poly 5x45.This report is 1 of 1 for (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, h6: 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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: product code: 186727545.Lot : 287473 the device history record (dhr) was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: september 04, 2020 visual inspection: the mis ti cfx fen poly 5x45 was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the internal threads of the screw head were observed to be peeled and torn.No other issues were observed with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed expedium 5.5 ti, cortical fix polyaxial screw assy, top loading shank investigation conclusion.The complaint condition was confirmed for the mis ti cfx fen poly 5x45.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 is traced to the user as the set screw was placed at an extreme angle which appears to have caused the complaint condition.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.
Event or Problem Description
This report is 2 of 2 for (b)(4).

• Brand Name: MIS TI CFX FEN POLY 5X45
• Common Device Name: ORTHOSIS,PEDICLE SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11088097
• Report Number: 1526439-2020-02457
• Device Sequence Number: 2694832
• Product Code: MNI
• UDI-Device Identifier: 10705034282459
• UDI-Public: 10705034282459
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: 186727545
• Device Catalogue Number: 186727545
• Device Lot Number: 287473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 01/12/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/11/2021; 02/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MON PED BOLT 6.25X45MM TI; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; MON PED BOLT 6.25X45MM TI; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS