MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	189401406
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: 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 depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, during a plif while the final tightening, torque was not applied to the sfx cross connector even though the surgeon tightened with considerable force.After many attempts to tighten, the set screw of the sfx cross connector got stripped and the sfx cross connector could not be removed.Procedure was completed successfully with thirty(30) minutes of surgical delay.The sfx cross connector in question is a consignment and thus no maintenance/check is performed on the values of torque.The tip of the sfx torque driver shaft may have been stripped.No further information is available.This report is for one (1) expedium sfx cross connector system connector a6 5.5 x 49-66mm.This is report 2 of 3 for complaint (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: h3, h6: a review of the receiving inspection (ri) for sfx,5.5,ti, med, size a6 was conducted identifying that lot number om11863 was released in one batch.Supplier: paragon medical-indiana - batch1: lot qty of 80 units were released on 10 june 2022 with no discrepancies.- batch2: lot qty of 20 units were released on 11 aug 2022 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 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 set screws of the sfx,5.5,ti, med, size a6 were found stripped.A damaged driver was used to thigh the set screw of the sfx,5.5,ti, med, size a6, these screws were found stripped, most likely for the usage of excessive force at the moment of tightened.Also, a incorrect rod [rod ø5.5 soft curv l70 ti (04.636.070)] was used with sfx,5.5,ti, med, size a6 causing stuck between devices.The expedium® sfx® cross connector system surgical technique guide 0902-90-048 rev.F was reviewed.Following relevant statements were found.Precautions: depuy spine spinal system components should not be used with components from other manufacturers.A dimensional inspection was not performed due to post manufacturing damage.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended user forces.Due to a several strip damage of the set screws and the incorrect used of components, the complaint condition was able to be replicated.¿the overall complaint was confirmed as the observed condition of the sfx,5.5,ti, med, size a6 [189401406/om11863] would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition, the root cause can be determined to be traced to the user.¿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.¿ as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.¿ 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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 16872956
• Report Number: 1526439-2023-00797
• Device Sequence Number: 12127661
• Product Code: KWP
• UDI-Device Identifier: 10705034168135
• UDI-Public: (01)10705034168135
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142460
• 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,Followup,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: 189401406
• Device Catalogue Number: 189401406
• Device Lot Number: OM11863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 06/09/2023; 07/14/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 06/29/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: SFX TORQUE HANDLE; SFX X20 TORQUE DRIVER SHAFT; UNK LOCKING/SET SCREWS
• Patient Sex: Unknown