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

Catalog Number 292902240

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
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> b)(4).Udi: b)(4).Upon visual inspection, it is observed that there is no physical damage except normal wear which would not contribute to the reported complaint condition.It is observed that the screw that holding the assembly is rusty.The device also makes some squeaking noise when it is operated.Dimensional inspection is not required as there is no physical damage observed with the device.A visual inspection, and document/specification review were performed as part of this investigation.The complaint cannot be confirmed as no broken features were observed with the device.A definitive root cause could not be determined for the reported problem.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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.

Manufacturer Narrative

(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Libertas: it was reported that on (b)(6) 2019, the (1) spotlight 2mm kerrison rongeur and (1) universal navigation adaptor has failed during the calibration during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves two (2) devices.

• 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): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9255386
• MDR Text Key: 176685841
• Report Number: 1526439-2019-52326
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 10705034225463
• UDI-Public: 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
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292902240
• Device Lot Number: 1108TM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2019
• 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