MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFLATE BALLOON/LARGE-STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 03.804.702S

Device Problem Deflation Problem (1149)

Patient Problem No Code Available (3191)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

Additional device product code: hrx.Complainant part is not expected to be returned for manufacturer review / investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 synthes reports an event in (b)(6) as follows: it was reported that during an unknown procedure on (b)(6) 2019 with the synflate system, it was impossible to deflate three (3) synflate l balloons in the vertebra.It was not possible to remove the synflate balloons with the working trocar.The procedure was completed by pulling the not completely deflated balloon to the top of the working trocar (3x) and completely removing both the trocar and the balloon.Procedure was delayed by thirty (30) minutes.Procedure was completed successfully by using same like product.Patient outcome is reported as stable.Concomitant device reported: balloon inflation system (part # unknown, lot # unknown, quantity 1); unknown torcar (part # unknown, lot # unknown, quantity 3).This report is for one (1) synflate balloon / large-sterile.This is report 2 of 3 for complaint (b)(4).

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.Part number: 03.804.702s, lot number: 0818005, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 17.Sep.2018, expiry date: 01.Aug.2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified 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/LARGE-STERILE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9136841
• MDR Text Key: 163162605
• Report Number: 8030965-2019-68860
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819525405
• UDI-Public: (01)07611819525405
• Combination Product (y/n): N
• PMA/PMN Number: K130146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Catalogue Number: 03.804.702S
• Device Lot Number: 0818005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS: TROCAR: SPINE; UNK - SYNFLATE/VBS
• Patient Outcome(s): Required Intervention