MAUDE Adverse Event Report: SYNTHES GMBH VERTEBRAL BODY SET/MEDIUM-STERILE; ARTHROSCOPE

Catalog Number 09.804.601S

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that during a percutaneous vertebroplasty on (b)(6) 2021, the surgeon was initially not able to dilate the stent large enough.The surgeon retracted the stent and retried insertion for another dilation.Then the reinforcing wire happened to damage the stent.The surgeon confirmed that his surgical technique triggered the event.No product defectiveness was involved.It was confirmed that no fragment had been left in the patient¿s body.The procedure was completed with less than thirty (30) minutes delay.This report is for a vertebral body set/medium-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: VERTEBRAL BODY SET/MEDIUM-STERILE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12211211
• MDR Text Key: 263569154
• Report Number: 8030965-2021-05988
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07611819471856
• UDI-Public: (01)07611819471856
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 09.804.601S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1