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

Model Number	03.702.150S
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem 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).
Additional 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
• Common Device Name: 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
• Report Number: 2939274-2021-06822
• Device Sequence Number: 6025582
• Product Code: KIH
• UDI-Device Identifier: 10886982262233
• UDI-Public: (01)10886982262233
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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 Sex: Male