MAUDE Adverse Event Report: SYNTHES GMBH ACCESS KIT 10 G DIAM TIP SIDE-OPEN DOUBL; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 03.804.514S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 10/11/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent a vertebral body augmentation for osteoporotic vertebral fracture.In the surgery, when the syringe in the syringe kit was attached to the cannula, the syringe did not fit properly.As a result, the syringe left behind a thread in the cannula, making it unusable.The surgeon used the substitute, and the surgery was completed successfully without any delay.The patient outcome was reported to be stable.This report involves one access kit 10 g diam tip side-open doubl.This is report 1 of 1 for (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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter facility name:(b)(6).E3: reporter is a j&j employee.G4: device is not distributed in the united states, but is similar to device marketed in the usa.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history review (dhr): part# 03.804.514s; lot # 23c06-2.Manufacturing site: sfm medical devices gmbh.Supplier: (b)(4).Release to warehouse date: 06 mar 2023.Expiration date: 06 mar 2028.A manufacturing record evaluation was performed for the finished article lot 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: ACCESS KIT 10 G DIAM TIP SIDE-OPEN DOUBL
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach 2425 ; SZ 2425
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18046202
• MDR Text Key: 327023304
• Report Number: 8030965-2023-13623
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819525375
• UDI-Public: (01)07611819525375
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.804.514S
• Device Lot Number: 23C06-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1