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

Model Number	287901009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgical procedure.During the procedure, when attempting to rotate the cage, the instrument fractured.Another cage system was used, and procedure was completed successfully.No patient harm, no surgical delay was reported.This complaint involves two (2) devices.This report is for (1) concorde inserter-bayonet.This report is 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.H3, h4, h6: a review of the receiving inspection (ri) for concorde inserter-bayonet was conducted identifying that lot number nn141762 was released in a single batch.Batch 1: lot qty of (b)(4) were released on (b)(6) 2018 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.Visual inspection: the concorde inserter-bayonet (part #: 287901009, lot #: nn141762) was received at us customer quality (cq).Upon visual inspection, there was no defect that could be observed.Device failure/defect identified? no.Dimensional inspection: no dimensional inspection was performed as there was no defect to the device.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as there was no defect that could be observed after inspection of the returned device.Moreover to ensure that the device was functional, the inner shaft (part # 287901102) was removed from the bayoneted outer shaft (part # 287901107).Resistance was noticed when pulling back the inner shaft due to the retaining ring (part # 287901106).The inner shaft was then re-inserted back in the outer shaft and it rotated freely inside the outer shaft.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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.

• Brand Name: CONCORDE INSERTER-BAYONET
• Common Device Name: DRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11929792
• Report Number: 1526439-2021-01094
• Device Sequence Number: 4395304
• Product Code: HWR
• UDI-Device Identifier: 10705034219899
• UDI-Public: 10705034219899
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: NN141762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 08/24/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CAGE/SPACER; UNKNOWN CAGE/SPACER.