MAUDE Adverse Event Report: ZIMMER SPINE PEDICULAR SOUNDER STRAIGHT FLEXIBLE; PROBE

Catalog Number 046W1AN00520

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported the instinct java pedicular sounder fractured in the vertebral body during surgery.The surgeon could not remove it and no further surgical information was provided.There were no reported patient impacts and there are no plans to revise at this time.

Event Description

It was reported the instinct java pedicular sounder fractured in the vertebral body during surgery.The surgeon could not remove it and no further surgical information was provided.There were no reported patient impacts and there are no plans to revise at this time.

Manufacturer Narrative

Additional information in d4: udi number, h4, and h6: method, results, and conclusions.This follow-up report is being submitted to relay additional information.The complaint is confirmed for one unreturned pedicular sounder str flexible for the failure of fractured tip and remains in patient.Visual inspection of the photo confirms that the tip of the sounder has fractured.Potential cause the cause of the damage cannot be determined at this time since there is no information available regarding how the sounder was being used or handled at the time of the damage.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

• Brand Name: PEDICULAR SOUNDER STRAIGHT FLEXIBLE
• Type of Device: PROBE
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 10645190
• MDR Text Key: 210388503
• Report Number: 3003853072-2020-00104
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 046W1AN00520
• Device Lot Number: A1432001A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other