MAUDE Adverse Event Report: DEPUY SPINE INC SPOT 4MM KERRISON RONGUER, 40; RONGEUR

Model Number	292902440
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, while checking the instruments, it was observed that the spot 2mm kerrison ronguer, 40 was not working properly.The handpiece is no longer secured so the instrument does not close properly.No patient consequences.This report is for one (1) spot 4mm kerrison ronguer, 40.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Reporter is a j&j sales representative.A product investigation was conducted.Visual inspection: the complaint device spot 4mm kerrison ronguer, 40 (product code: 292902440, lot number: 0410tm) was returned to (b)(4) for investigation.During visual inspection, the ball and socket assembly was found detached.Functional test: the device did not work as intended as the assembly facilitating the movement of the handle was found broken.Dimensional inspection: a dimensional inspection as this was identified t be a post manufacturing damage.Document/specification review: as the manufacturing date was not available, the current revisions of the drawing were released.(b)(4) rev c (current and manufactured).Conclusion: the returned device was broken due to which the device was non-functional.Hence, the complaint was confirmed.A definitive assignable root cause could not be determined from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.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 history lot - as per (b)(4) manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.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: SPOT 4MM KERRISON RONGUER, 40
• Common Device Name: RONGEUR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13004013
• Report Number: 1526439-2021-02547
• Device Sequence Number: 4216411
• Product Code: HTX
• UDI-Device Identifier: 10705034225500
• UDI-Public: (01)10705034225500
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 292902440
• Device Catalogue Number: 292902440
• Device Lot Number: 0410TM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown