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

Model Number 07.702.040S

Device Problems Use of Device Problem (1670); Device Difficult to Maintain (3134)

Patient Problem Not Applicable (3189)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

Exp date unknown.Occupation: j&j rep.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 (b)(6) 2019, patient underwent an unknown procedure, the traumacem v+ bone cement injectable was defective as it hardened within a couple of minutes after mixing making it very difficult to draw up into the syringes.A new product was opened and used.There were a couple of minutes of surgical delay.The product was discarded before use.So, there was no direct patient involvement.Procedure and patient outcome were unknown.Concomitant device reported: unknown traumacem syringes (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history lot part: 07.702.040s, lot: 7g53210, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 17 october 2017, expiry date: 31 july 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 V+ BONE CEMENT INJECTABLE
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8760523
• MDR Text Key: 150016843
• Report Number: 2939274-2019-59017
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10886982262257
• UDI-Public: (01)10886982262257
• Combination Product (y/n): N
• PMA/PMN Number: K170802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 07.702.040S
• Device Catalogue Number: 07.702.040S-US
• Device Lot Number: 7G53210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• Patient Sequence Number: 1