MAUDE Adverse Event Report: SYNTHES GMBH TRAUMACEM(TM) V+ SYRINGE KIT - STERILE; DISPENSER, CEMENT

Catalog Number 03.702.150S

Device Problem Failure to Eject (4010)

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

Event Date 09/04/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part: 03.702.150s, lot: 0012735, manufacturing site: (b)(4), supplier: symatese device, release to warehouse date: 03 february 2020, expiration date: 01 february 2025, a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 on (b)(6) 2021 during a procedure when preparing the cement for use, after mixing we were unable to fill the syringes as the cement was unable to come through.All steps were correctly followed.The procedure was completed successfully but without the use of augmentation.There was no delay and no patient impact.This report is for one (1) traumacem(tm) v+ syringe kit - sterile.This is report 1 of 2 for complaint (b)(4).

• Brand Name: TRAUMACEM(TM) V+ SYRINGE KIT - STERILE
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12565366
• MDR Text Key: 274560021
• Report Number: 8030965-2021-08304
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 07611819476523
• UDI-Public: (01)07611819476523
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.702.150S
• Device Lot Number: 0012735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2021
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1