MAUDE Adverse Event Report: SYNTHES GMBH ACCESS KIT 4.7; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 03.804.612S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 05/12/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.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 synthes reports an event in (b)(6) as follows: it was reported that this was a vbs for treating centrum fracture on (b)(6) 2022.The procedure progressed up to cement application and sleeve removal without any issue.Then, the surgeon recognized that some blood and air seemed to come out of the incision.The procedure was completed without surgical delay.However, the surgeon saw something wrong with the patient postoperatively and finally confirmed pneumothorax.The surgeon commented as follows: when the trocar in the vbs kit was in use, the trocar might have damaged the lung.Anesthesia might been involved with the event.A primary cause of the event was not identified.No further information is available.This report is for one (1) access kit 4.7.This is report 1 of 1 for complaint (b)(4).

• Brand Name: ACCESS KIT 4.7
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14643503
• MDR Text Key: 293654020
• Report Number: 8030965-2022-03847
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 07611819649637
• UDI-Public: (01)07611819649637
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.804.612S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Sex: Female