MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE PROBE - CURVED LUMBAR LENKE

Catalog Number 07.02072.001

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/11/2020

Event Type  Injury  

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 as the surgeon began to mallet the vitality instrument at s1 pedicle, hard bone was encountered.After a second strike to the instrument, the hard bone was penetrated and the instrument went through the anterior wall of the sacrum and the vitality instrument was stuck.The surgeon was able to pull the instrument out; however, the distal tip of the instrument fractured off and remained in the patient.There are no reports of surgery delayed.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h1, h2, h3, h6, h10.D4: udi # (b)(4).The complaint is confirmed for one curved lumbar lenke vitality for the reported failure of fractured/broke tip.The product was not returned, however x-ray photos were received and reviewed.The pictures shows the broken part of the distal tip of the probe.The brightness of the bone in the x-ray supports the claim of hard bone.However, the product is not returned so an evaluation is unable to be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.Per dhr review, the part was likely conforming when it left zimmer biomet control.Based on the information provided, the cause can possibly be attributed to an off-axis force applied when the device was inserted causing it to fracture at the point just above the bone; however, at this time a conclusive root cause cannot be identified.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: PEDICLE PROBE - CURVED LUMBAR LENKE
• Type of Device: PROBE
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10448590
• MDR Text Key: 204208614
• Report Number: 3012447612-2020-00499
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02072.001
• Device Lot Number: 110854
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other