MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM TOP NOTCH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179771555
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
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 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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 during a rod extension procedure in the thoracolumbar spine the rod connector became deformed.Cross-threading was done on the first rod connector and the second rod connector became deformed during the rod connection.The procedure was completed with another replacement with less than a thirty (30) minute surgical delay.Concomitant devices: single inner set screw (part# 179702000, lot# 286895, qty 1), single inner set screw (part# 179702000, lot# 283108, qty 1), unknown rod (part# unknown, lot# unknown, quantity unknown).This report is for one (1) expedium spine system side loading open/open top notch connector 5.5 x 5.5mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
This is report 1 of 3 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 subject device has been 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.Event date.
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.H3, h4, h6: visual analysis of the returned sample revealed that connector component inner threads were slightly stripped.The dimensional inspection was not performed due to the post-manufacturing damage.The observed stripped internal threads of the connector device was consistent with a random component failure that may have been caused by exposure to unintended/overt forces.It should be noted that as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as visual inspection of the received device confirmed the stripped condition.While no definitive root cause could be determined, it is possible that the observed stripped condition may be occurred due to a random component failure that may have been caused by exposure to unintended/overt forces.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 history lot: a review of the receiving inspection (ri) for conn o/o sd top ntch 5.5x5.5 t was conducted identifying that lot number nw260469 was released in a single batch.Batch1: lot qty of units were released on 29 sep 2020 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.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 TOP NOTCH
• 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: 11733831
• Report Number: 1526439-2021-00809
• Device Sequence Number: 3591884
• Product Code: NKB
• UDI-Device Identifier: 10705034077819
• UDI-Public: 10705034077819
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• 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): 04/01/2021

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: 179771555
• Device Catalogue Number: 179771555
• Device Lot Number: NW260469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 04/29/2021; 05/20/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 05/19/2021; 05/26/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONN O/O SD TOP NTCH 5.5X5.5 T; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; UNKNOWN RODS