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  

Manufacturer Narrative

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

It was reported that on an unknown date in 2021, patient underwent orthopedic procedure.During a right femur trochanteric fixation nail-advanced (tfna) insertion the surgeon requested traumacem.During the preparation of the traumacem, the tech had difficulty mixing the cement, he was unable to compress the t handle to "fully compressed stop" position.The cement was difficult to load into the small syringe and the doctor was unable to inject the cement into the tfna lag screw.Surgeon abandoned the cement implantation.There was a (5) minutes of surgical delay noted.The procedure was successfully completed.There was no patient consequences.This report is for (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): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12463598
• MDR Text Key: 271293385
• Report Number: 2939274-2021-05386
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• 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: 08/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 91