MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFLATE BALLOON/SMALL- STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Model Number 03.804.700S

Device Problems Inflation Problem (1310); Mechanical Problem (1384)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, the patient underwent for a surgery.During the surgery, the surgeon noticed that where reviewing x-ray, the synflate vertebral balloon leaked fluid at the junction of the balloon with the stylet.It was unknown if there was a surgical delay.The procedure successfully completed.The patient outcome is unknown.Concomitant device reported: unk stylet (part# unknown; lot# unknown; quantity: unknown).This complaint involves one (1) device.This report is for (1) synflate balloon/small sterile.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: patent identifier: (b)(6).Additional product code: hrx.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- this complaint is not confirmed as a functional test could not be performed to confirm the leak, and no x-rays were returned to show the leakage.However, the balloon is burst/cracked.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot = part #: 03.804.700s, synthes lot #: j002415, supplier lot #: j002415, release to warehouse date: 17 dec 2020, supplier: (b)(4), no ncr's generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.

• Brand Name: SYNFLATE BALLOON/SMALL- STERILE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• 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: 12900854
• MDR Text Key: 287331271
• Report Number: 2939274-2021-06863
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034722702
• UDI-Public: (01)10705034722702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.804.700S
• Device Catalogue Number: 03.804.700S
• Device Lot Number: J002415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SYNFLATE BALLOON/SMALL- STERILE
• Patient Sex: Male