MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE CLEAR 30DEG 5MM; ACCESSORIES, ARTHROSCOPIC

Model Number	163005530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that a patient underwent a posterior lumbar interbody fusion (plif) procedure to treat the lumbar spinal canal stenosis (l4-5) on (b)(6) 2019.During the procedure the surgeon removed degenerated disc with the concorde clear 30 degrees in question from the right side (surgeon¿s side) without issue.Next, the surgeon inserted it from the left side (surgeon¿s side).When surgeon started disc removal, it broke where the tubing¿s diameter becomes larger to 8mm (80mm from the tip guard).It was confirmed by postoperative x-rays that no fragment was left in the patient¿s body.Procedure was completed successfully.Patient's outcome is reported as stable.No further information is available.This is report 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.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
Product complaint #: (b)(4).Udi: (b)(4).H3: correction.H6: additional information.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.Upon visual inspection, it is observed that the cylindrical shaft of the device got broken.The rest of the device shows normal wear which would not contribute to the complaint condition.A manufacturing related potential cause was not suspected, therefore, no manufacturing record evaluation is required.Visual inspection, dimensional inspection, and document specification review of the received device was performed.The complaint is being confirmed as it is observed that the cylindrical shaft got broken.While a definitive root cause could not be determined, it is possible that the device might have got encountered with unintended forces.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to 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.

• Brand Name: CONCORDE CLEAR 30DEG 5MM
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9396474
• Report Number: 1526439-2019-52524
• Device Sequence Number: 16677571
• Product Code: HRX
• UDI-Device Identifier: 10705034507378
• UDI-Public: (01)10705034507378
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2019

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 Expiration Date: 07/30/2021
• Device Model Number: 163005530
• Device Catalogue Number: 163005530
• Device Lot Number: 65924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 01/03/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/26/2019; 01/07/2020
• Patient Sequence Number: 1