MAUDE Adverse Event Report: SYNTHES GMBH SYNFLATE BALLOON/MEDIUM- STERILE; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 03.804.701S

Device Problem Inflation Problem (1310)

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

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

Additional procode: hrx.Part:03.804.701s.Synthes lot: h892250.Supplier lot: n/a.Release to warehouse date: october 22, 2020.Expiration date: n/a.Supplier: (b)(6).No nonconformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Customer quality investigation: the instrument(s) was not returned, and the investigation will be completed based on the received image(s).The image(s) was reviewed, and the complaint condition was confirmed as the image showed the needle sticking out of the balloon indicating it did not inflate correctly.As the instrument(s) was not returned, an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was performed, and no issues were noted.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 the (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, the blue end on the inflating guide was sticking out of the balloon, meaning that the balloon inflated unevenly.The defect was noticed once the balloon was removed from the patient.The equipment was discarded, and replacements used.Procedure was completed with a ten (10) minute delay.There was no patient consequence.This report is for a synflate balloon/medium- sterile.This is report 1 of 1 for (b)(4).

• Brand Name: SYNFLATE BALLOON/MEDIUM- STERILE
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11850081
• MDR Text Key: 252627761
• Report Number: 8030965-2021-04034
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819525399
• UDI-Public: (01)07611819525399
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130146
• 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: 04/21/2021

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: 03.804.701S
• Device Lot Number: H892250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1