MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI OPN ILIAC CN 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	179797040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procodes: kwp, kwq, mnh, mni, osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2020, the open polyaxial lateral connector was broken during the cap finalize step.The connector head and rod were disassembled at the time.A new one was used instead.Procedure was completed successfully with a ten (10) minute delay.There was no patient consequence.This report is for an expedium 5.5 open connector.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.H10 additional narrative: investigation summary: complaint summary: the open polyaxial lateral connector was broken during the cap finalize step.(the connector head and rod was disassembled.) the implant(s) was not returned and instead the investigation will be done based on the supplied image(s) from the attachments.The image(s) was reviewed and the complaint condition for broken could be confirmed as the image provided shows the implant in 3 separate pieces.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.Investigation summary: visual inspection: the 5.5 ti opn iliac cn 40mm (p/n: 179797040, lot number: tbacxw) was received at us customer quality (cq).Visual inspection of the complaint device showed the rod component had broken.Device failure/defect identified? yes.Dimensional inspection: drawing.Specified dimensions: rod od = measured dimensions: rod od = conforming device used - caliper ca148p.Document/specification review: (current and manufactured) was reviewed.(current and manufactured) was also reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the rod component has broken.No definitive root cause could be determined based on the provided information.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 5.5 ti opn iliac cn 40mm was conducted identifying that lot number tbacxw was released in a single batch.Batch1: lot was released on march 5, 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.,a review of the receiving inspection (ri) for 5.5 ti opn iliac cn 40mm was conducted identifying that lot number tbacxw was released in a single batch.Batch1: lot was released on march 5, 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.Device history review: 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: 5.5 TI OPN ILIAC CN 40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10447742
• Report Number: 1526439-2020-01513
• Device Sequence Number: 3558305
• Product Code: NKB
• UDI-Device Identifier: 10705034082929
• UDI-Public: (01)10705034082929
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2020

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: 179797040
• Device Catalogue Number: 179797040
• Device Lot Number: TBACXW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 10/06/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/02/2020; 10/21/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN RODS; UNKNOWN RODS.