MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT - STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Model Number 07.702.040S

Device Problem Failure to Discharge (1169)

Patient Problem Not Applicable (3189)

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Expiration date and lot number unknown.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 as no product was received.Investigation summary: 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 during hip surgery on (b)(6) 2020, the traumacem v + injectable bone cement would not dispense from the mixer.The procedure successfully completed by opening another traumacem bone cement.There was a 15 minutes surgical delay.Patient status is unknown.Concomitant device reported: unknown mixer (part # unknown, lot # unknown, quantity #1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT - STERILE
• Type of Device: POLYMETHYLMETHACRYLATE BONE 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9940778
• MDR Text Key: 188652287
• Report Number: 2939274-2020-01762
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10886982262257
• UDI-Public: (01)10886982262257
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 07.702.040S
• Device Catalogue Number: 07.702.040S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2020
• 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
• Patient Age: 76 YR