MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A3 5.5 X 32-37MM; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Model Number	189401303
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: d2: additional procodes: kwp, nkb, mni, kwq, mnh.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthese 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 japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent a spinal fusion (t8-l2) for a vertebral body fracture.After temporary fixation of the sfx cross connector was completed, the surgeon attempted final tightening with a sfx torque driver shaft.However, the shaft got stripped multiple times while engaged with the set screw of the sfx cross connector.The final tightening could not be completed, so the surgeon switched from the sfx cross connector to another standard sfx f9.The procedure was completed successfully with no surgical delay.No further information is available.This report is for an expedium sfx cross connector system connector a3 5.5 x 32-37mm.This is report 1 of 2 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.A review of the receiving inspection (ri) for t-pal proti, 10x9x28 mm, was conducted identifying that lot number om11902 was released in one batch.Batch1: lot qty of (b)(4) units were released on 09 aug 2022 with no discrepancies.Supplier: (b)(4).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.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 A3 5.5 X 32-37MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17289907
• Report Number: 1526439-2023-01246
• Device Sequence Number: 6347698
• Product Code: OSH
• UDI-Device Identifier: 10705034168036
• UDI-Public: (01)10705034168036
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062196
• 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

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: 189401303
• Device Catalogue Number: 189401303
• Device Lot Number: OM11902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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: UNK - INSERTION INSTRUMENTS: EXPEDIUM SFX; UNK - LOCKING/SET SCREWS: EXPEDIUM SFX
• Patient Sex: Unknown