MAUDE Adverse Event Report: DEPUY SPINE INC CONCORDE BONE FUNNEL 8MM; MISC ORTHO SURGICAL INSTR

Model Number	287908008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the receiving inspection (ri) for the concorde bone funnel 8mm was conducted identifying that lot number x0710 was released in a single batch.Batch 1: released on august 08, 2010 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 bone funnel 8mm was received at us customer quality (cq).The device was received with the funnel separated from the funnel tube.The weld that connected the two components failed.Due to the weld failure, the device was broken.No other defects were identified.The received condition was consistent with the complaint condition thus the complaint as confirmed.Dimensional inspection: measured dimensions: tube outer diameter = conforming.Funnel thickness = conforming.Document/specification review: drawing(s) reviewed: (current & manufactured revisions) assembly, funnel.Conclusion: the overall complaint was confirmed for the received concorde bone funnel 8mm as the weld that connected the tube and funnel failed.Although no definitive root-cause can be determined, it is possible the device experienced unintended forces while in use.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 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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that patient underwent a plif (posterior lumbar interbody fusion) procedure (l4-5) treating spinal stenosis on (b)(6) 2019.While the surgeon was hammering the black part of the bone funnel, the silver funnel came off.A replacement was available for use.It was confirmed that no fragment left in the patient's body.The procedure was completed without surgical delay.Concomitant devices: hammer/impaction instrument (part: unknown, lot: unknown, quantity: unknown).This report is for a concorde bone funnel 8mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).

• Brand Name: CONCORDE BONE FUNNEL 8MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9538230
• Report Number: 1526439-2020-00017
• Device Sequence Number: 2334458
• Product Code: LXH
• UDI-Device Identifier: 10705034220147
• UDI-Public: (01)10705034220147
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 287908008
• Device Catalogue Number: 287908008
• Device Lot Number: X0710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN IMPACTION INSTRUMENTS