MAUDE Adverse Event Report: DEPUY SPINE INC SPOT 2MM KERRISON RONGUER, 40; RONGEUR

Model Number 292902240

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.Visual inspection: the spot 2mm kerrison ronguer, 40 (p/n: 2929-02-240, lot #: tm1203133) was returned and received at us customer quality (cq).Upon visual inspection, the device was received fell apart due to a loose set screw.The stake on the set screw failed.There were scratches but have no impact on the functionality of the device.No other issues were identified with the returned device.Functional test: the functional test was performed on the returned device.The device was able to reassemble and the device was able to function as intended.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review since the exact manufactured date of the device was not identified, the current revision of drawing was reviewed: 2,3 and 4 mm kerrison rongeurs, pipeline ii.Complaint confirmed? yes, the device received was fell apart.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the spot 2mm kerrison ronguer, 40 (p/n: 2929-02-240, lot #: tm1203133) there is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential root cause could be due to unintended forces applied to the device.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 Description

It was reported that on (b)(6) 2020 the spotlight 2mm kerrison rongeur was broken during a reverse logistics audit of returned devices at millstone.There was no patient involvement and no additional information is available.This report is for one (1) spot 2mm kerrison ronguer, 40.This is report 1 of 1 for (b)(4).

• Brand Name: SPOT 2MM KERRISON RONGUER, 40
• Type of Device: RONGEUR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9962195
• MDR Text Key: 196136152
• Report Number: 1526439-2020-00853
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 10705034225463
• UDI-Public: (01)10705034225463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 292902240
• Device Catalogue Number: 292902240
• Device Lot Number: TM1203133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1