MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TRAUMACEM(TM) V+ SYRINGE KIT - STERILE; DISPENSER, CEMENT

Model Number 03.702.150S

Device Problem Failure to Eject (4010)

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

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was reported that on an unknown date, patient underwent for an orthopedic surgical procedure.The augment was mixed according to instructions and cannula was prefilled with 4ml of augment and stopped when it started coming out.When the surgeon put the cannula into the sleeve into the helical blade to insert the augment, nothing would come out.The surgery was completed with a surgical delay of 7 minutes.There was no patient consequence reported.Concomitant device reported: unk - guides/sleeves/aiming: sleeve (part# unknown; lot# unknown; quantity: 1); unk - nail head elements: tfna helical blade (part# unknown; lot# unknown; quantity: 1); unk - insertion instrument (part# unknown; lot# unknown; quantity: 1).This complaint involves three(3) devices.This report is for (1) traumacem(tm) v+ syringe kit - sterile.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Product complaint #: (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 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: TRAUMACEM(TM) V+ SYRINGE KIT - STERILE
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12871087
• MDR Text Key: 281337637
• Report Number: 2939274-2021-06822
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10886982262233
• UDI-Public: (01)10886982262233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.702.150S
• Device Catalogue Number: 03.702.150S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• 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
• Treatment: TRAUMACEM V+ INJECTION CANNULA TFNA -S; TRAUMACEM(TM) V+ INJECTABLE CEMENT -S; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
• Patient Age: 94 YR
• Patient Sex: Male