MAUDE Adverse Event Report: AESCULAP AG ENNOVATE LUMBAR PEDICLE PROBE STR; ENNOVATE INSTRUMENTS

Model Number SZ242R

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The instrument arrived mounted but with broken welding seam.Test performed was microscope and digital camera.A visual inspection of the broken welding seam.For this, we screwed the thread of the shaft fully into the handle.The seam seems even welded and it is outwardly without visible defects.In the next step we unscrewed shaft and handle and inspected the residues of the seam at both sides (handle and shaft).At both sides there are continuous residues visible.The manufacturing documents have been checked and found to be according to specification valid during the time of production.There currently no further complaints with this lot at hand.The problem is most probably design and/or manufacturing related.

Event Description

It was reported by the healthcare professional "while using the probe turning it left and right.The surgeon maintained while pulling the probe out of the body with the ball handle in his hand and the probe stuck in patient vertebra.They had to screw it again but this is lose so its workable anymore for the surgery.Trying to connect every time the handle - but could work properly.".

• Brand Name: ENNOVATE LUMBAR PEDICLE PROBE STR
• Type of Device: ENNOVATE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 8337300
• MDR Text Key: 136112319
• Report Number: 9610612-2019-00041
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SZ242R
• Device Catalogue Number: SZ242R
• Device Lot Number: 52427942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/22/2019
• Device Age: 6 MO
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention