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

Catalog Number	292902240
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > 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.
Additional 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 or Problem 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
• Common Device Name: RONGEUR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9255386
• Report Number: 1526439-2019-52326
• Device Sequence Number: 11232458
• Product Code: HTX
• UDI-Device Identifier: 10705034225463
• UDI-Public: 10705034225463
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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 Catalogue Number: 292902240
• Device Lot Number: 1108TM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1