MAUDE Adverse Event Report: DEPUY SPINE INC CONCORDE INSERTER-BAYONET; DRIVER, PROSTHESIS

Model Number	287901009
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during the posterior lumbar interbody fusion (plif) for the degenerative disease with the cage (proti-concorde cage) in question.Both the nurse and the surgeon could not grasp it vertically with the inserter.There was no problem with the handling of the cage and inserter.They used a new cage and was able to be grasped vertically with the inserter.Procedure was completed successfully without any surgical delay.This report is for one (1) concorde inserter-bayonet.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
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.H3, h6: the product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the concorde inserter-bayonet had no issues observed.The dimensional inspection was not performed due to the design of the device.No observable device defects were noted with the concorde inserter-bayonet.A functional test was not performed as the returned mating implant in question was noted to have stripped threads.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint cannot be confirmed for the concorde inserter-bayonet as no issues were observed with the device.A definitive root cause for the reported issue cannot be determined from the available information.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? the following drawings reflecting the current and manufactured revisions were reviewed: quicksilver inserter assembly, 9w bayoneted 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.H10 additional narrative: h6: part: 287901009.Synthes lot: nn150586.Supplier: (b)(4) batch1: released on april 15, 2019 with no nonconformance reports (ncr) generated during production.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.

• Brand Name: CONCORDE INSERTER-BAYONET
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13080521
• Report Number: 1526439-2021-02620
• Device Sequence Number: 11831806
• Product Code: HWR
• UDI-Device Identifier: 10705034219899
• UDI-Public: (01)10705034219899
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: 287901009
• Device Catalogue Number: 287901009
• Device Lot Number: NN150586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 02/18/2022; 02/28/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 02/18/2022; 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2019
• 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: CONCORDE PROTI, 5DG,9X9X23 MM.; UNKNOWN INSERTION INSTRUMENTS.
• Patient Sex: Unknown