MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X16MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	1020-35-116
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
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.Additional device product codes: kwp.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.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
It was reported that on (b)(6).2023, during a c2-t2 surgery, the surgeon was putting a rod onto the screw and was manipulating the symphony tulip with a heavy needle holder.The surgeon noticed a piece of metal that looked like threading coming off the tulip.After the surgeon implanted both of the rods and final tightened, the surgeon removed the piece of metal from the tulip with forceps.There was no adverse event as a result of the incident.There was no other medical intervention required.This report involves one symphony oct system polyaxial screw diameter 4.0 rod, 3.5x16mm.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.H10 additional narrative: h6: a manufacturing record evaluation cannot be performed due to lot number being unknown.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received image(s).Visual analysis of the photo revealed that there is a small piece of metal, however is not possible to confirm if it was part of the 4.0 ply scrw 3.5x16.Therefore, the alleged condition cannot be confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 4.0 ply scrw 3.5x16.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.

• Brand Name: SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X16MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16505570
• Report Number: 1526439-2023-00446
• Device Sequence Number: 12317341
• Product Code: NKG
• UDI-Device Identifier: 10705034508702
• UDI-Public: (01)10705034508702
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K190895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 1020-35-116
• Device Catalogue Number: 102035116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN FORCEPS.; UNKNOWN RODS.
• Patient Sex: Unknown