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

Catalog Number 03.804.514S

Device Problems Problem with Sterilization (1596); Device-Device Incompatibility (2919)

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

Event Date 06/07/2023

Event Type  malfunction  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.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.H3, h4, h6: 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 lot part# 03.804.514s lot#22e19-1 manufacturing site: werk selzach logistik supplier: sfm medical devices gmbh release to warehouse date: 19 may 2022 expiration date: 19 may 2027 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.

Event Description

Device report from synthes reports an event in japan as follows: it was reported that during a percutaneous vertebroplasty procedure on (b)(6)2023, when the syringe and the cement needle were taken out of the kit, the surgeon said that he could not connect the two because something was stuck in the cement needle.A nurse tried to connect them, and she couldn¿t either for the same reason.The nurse was unable to remove the substance stuck in the cement needle using tweezers.A new kit was opened, and the procedure was completed successfully with a 30-minute delay.There was no adverse consequence to the patient.This report involves one access kit 10 g diam tip side-open doubl.This is report 1 of 1 for (b)(4).

• 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: 17209761
• MDR Text Key: 318118397
• Report Number: 8030965-2023-08040
• 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,Company Representative
• 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: 06/27/2023
• 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: 22E19-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1