MAUDE Adverse Event Report: DEPUY SPINE INC CONCORDE BONE FUNNEL 8MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	287908008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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 synthes reports an event in (b)(6) as follows: it was reported that this was an unknown procedure performed on (b)(6) 2020.While the surgeon was tapping the bone funnel with an unknown device, the connecting section between the silver funnel and the rod broke.No further information is available.Concomitant devices reported: unknown rod (part# unknown, lot# unknown, quantity 1), unknown impaction instruments: hammer/mallet: spine (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for one (1) concorde bone funnel 8mm.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.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could be confirmed as the device has broken into multiple pieces.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 BONE FUNNEL 8MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10272457
• Report Number: 1526439-2020-01338
• Device Sequence Number: 860195
• 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): 06/29/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/22/2020
• 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: UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: SPINE; UNKNOWN RODS