MAUDE Adverse Event Report: DEPUY SPINE INC KERISON RONGEUR LONG 7X40 DEG

Catalog Number 6300807

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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: broken instrument.

Manufacturer Narrative

Product complaint # (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Udi: (b)(4).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.The rongeur showed signs of wear as nicks and discoloration were present along it¿s surfaces.There was no evidence of a physical device breakage.The reported condition of broken was not confirmed.The device was functionally tested.When engaged, the rongeur successfully closed however it remained jammed when the handle was released.A light application of force to the handle was required to un-jam the rongeur.Further testing showed that the rongeur made an audible squeaking noise when the handle was engaged, and the rongeurs motion was not smooth.The rongeur was observed to be functionally jammed.A manufacturing record evaluation was not performed since the lot # of the device was unknown.Although no definitive root-cause can be determined for the functional issue, the device may be poorly lubricated causing internal components to jam when engaged.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.

• Brand Name: KERISON RONGEUR LONG 7X40 DEG
• Type of Device: RONGEUR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9245788
• MDR Text Key: 177869718
• Report Number: 1526439-2019-52307
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 10705034007465
• UDI-Public: 10705034007465
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6300807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1