MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MON PED BOLT 6.25X45MM TI; ORTHOSIS,PEDICLE SPINAL FIXATION

Model Number	177016245
Medical Device Problem Code	Device-Device Incompatibility (2919)
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.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 one (1) device.This report is for (1) mon ped bolt 6.25x45mm ti.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A review of the mon ped scw n/c 6.25x45mm ti was conducted identifying that lot number j287473 was released in a single batch.Batch1: lot qty of (b)(4) were released on 08 aug 2005 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: MON PED BOLT 6.25X45MM TI
• 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: 11039797
• Report Number: 1526439-2020-02442
• Device Sequence Number: 13709055
• Product Code: MNI
• UDI-Device Identifier: 10705034053523
• UDI-Public: 10705034053523
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K010576
• 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
• 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: 177016245
• Device Catalogue Number: 177016245
• Device Lot Number: J287473
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 02/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS