MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SYMPHONY OCT SYSTEM POLYAXIAL SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	1020-40-328S
Medical Device Problem Codes	Material Deformation (2976); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: brand name: symphony oct system polyaxial screw reduction cannulated diameter 4.0 rod, 4.0x28mm 3.5 4.0.Additional device product codes: kwp.Reporter is a j&j employee.A device history record (dhr) review was not conducted as manufacturing records related to the provided lot number were not available.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the 4.0 can/red scrw 4.0x28 was broken from both ends of the reduction head, fragments were not returned.The poly screw is bent along the neck between the head and the threaded shaft.Additionally, the proximal section of the threads has several nicks.A dimensional inspection for the 4.0 can/red scrw 4.0x28 was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 4.0 can/red scrw 4.0x28 would contribute to the complained device issue.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.Drawing/specifications reviewed? yes, reviewed.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 japan as follows: it was reported that this was a posterior cervical fusion (c2 right) for a c2 fracture on (b)(6) 2022.The surgeon tried to remove the tab before insertion because the tab was interfered.When the surgeon tried to remove the tab of the tab screw with a tab breaker, the screw moved with the tab breaker, and the tab could not be removed.The surgeon put the screw in the hole behind the counter of the h2h and removed the tab.Then, the screw threads were scratched and bent at the screw neck.A new screw was used instead of the tab screw in question.The surgery was completed successfully without any surgical delay.No further information is available.This report involves one symphony oct system polyaxial screw reduction cannulated diameter 4.0 rod, 4.0x28mm 3.5 4.0.This is report 1 of 1 for (b)(4).

• Brand Name: SYMPHONY OCT SYSTEM POLYAXIAL SCREW
• 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: 15924248
• Report Number: 1526439-2022-02076
• Device Sequence Number: 17814944
• Product Code: NKG
• UDI-Device Identifier: 10705034520872
• UDI-Public: 10705034520872
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 1020-40-328S
• Device Catalogue Number: 102040328S
• Device Lot Number: 282746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/06/2022
• 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 OTHER PRODUCTS
• Patient Sex: Unknown