MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM VERSE SPINE SYSTEM FLEX CLIP REDUCER, THREADED INSERT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	299704272
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in australia as follows: it was reported that during a spinal fusion procedure on (b)(6) 2022, the surgeon was attempting to attach the flex clip reducer handle to the flex clip reducer threaded insert.They were not able to attach it as the flex clip reducer threaded insert was too thick.The flex clip reducer insert was exchanged for one in the verse std set and it worked.The patient appeared to be unaffected.An extra 10 minutes of surgery time was added, and the procedure was successfully completed.There were no patient consequences.No further information is available.This report involves one expedium verse spine system flex clip reducer, threaded insert.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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
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.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment visual analysis of the photo revealed that the flex clip reducer thread insrt had no signs of issue or defect.Functional issues cannot be assessed through photo evidence.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 the flex clip reducer thread insrt.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.
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.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 there was no damage or defects with the flex clip reducer thread insrt.A dimensional inspection was performed for the flex clip reducer thread insrt and met specifications.A functional test was unable to be performed due to mating device not returned.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the flex clip reducer thread insrt was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.Dimensional inspection: conforming.Device history lot: a review of the receiving inspection (ri) for flex clip reducer thread insrt was conducted identifying that lot number gm42681ne was released in one batch.Batch 1: lot qty of (b)(4) units were released on 7 jul 2015 with no discrepancies.Supplier: (b)(4) medical.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.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.D9: device returned to manufacturer.

• Brand Name: EXPEDIUM VERSE SPINE SYSTEM FLEX CLIP REDUCER, THREADED INSERT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15969839
• Report Number: 1526439-2022-02130
• Device Sequence Number: 5229341
• Product Code: LXH
• UDI-Device Identifier: 10705034477206
• UDI-Public: (01)10705034477206
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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: Physician
• 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: 299704272
• Device Catalogue Number: 299704272
• Device Lot Number: GM42681NE
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 01/06/2023; 01/13/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/12/2023; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXP VERSE (SECOND SURGEON TRAY); FLEX CLIP REDUCER, HANDLE
• Patient Sex: Unknown