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

Model Number	189401406
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
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 device product codes: mnh, osh, nkb, mni, kwp.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility name: (b)(6) hospital.Reporter is a j&j employee.A review of the receiving inspection (ri) for sfx,5.5,ti, med, size, race was conducted identifying that lot number om11624 was released in one batch.Supplier: (b)(4).Batch1: lot qty of 94 units were released on 03 nov 2021 with no discrepancies.Batch2: lot qty of 06 units were released on 01 oct 2021 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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 synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the surgeon performed an interbody fusion (l3 to l5) for spondylolisthesis.The leftmost of the three set screws was properly torqued by the torque driver shaft in question.The rightmost set screw did not torque out, and the tip of the torque driver shaft got stripped.Although the surgeon tried to torque the set screw several times, the driver shaft was idled.The center set screw also did not torque out due to idling of the torque driver shaft.The surgeon tightened the set screws with a qc polyaxial screwdriver.The rightmost set screw itself got stripped, and the center set screw was tightened to some extent.Nonetheless the set screws got stripped, the transverse was tightened to some extent.The surgeon determined that it was difficult to replace the transverse, and the surgery was completed successfully without any surgical delay.It was confirmed by x rays that there were no broken pieces in the patient¿s body.This report involves one expedium sfx cross connector system connector a6 5.5 x 49-66mm.This is report 2 of 2 for (b)(4).

• Brand Name: EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 15630862
• Report Number: 1526439-2022-01841
• Device Sequence Number: 5983180
• Product Code: KWQ
• UDI-Device Identifier: 10705034168135
• UDI-Public: 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
• Device Implanted Year: 2022
• 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: 189401406
• Device Catalogue Number: 189401406
• Device Lot Number: OM11624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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 X20 TORQUE DRIVER SHAFT; UNKNOWN LOCKING/SET SCREWS
• Patient Sex: Unknown