MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TRAUMA SYRING KIT 4*1 ML 2*2 ML; DISPENSER, CEMENT

Model Number 03.702.150S

Device Problem Failure to Eject (4010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Part: 03.702.150s, lot: 8042526, manufacturing site: selzach, supplier: symatese device, release to warehouse date: 05.Jun.2018, expiry date: 31.Mar.2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.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.

Event Description

It was reported that on (b)(6) 2020 the traumacem v+ injection cannula and traumacem v+ syringe kit would not inject into syringes.It was unknown when the issue was discovered.There was no patient involvement.This report is for one (1) trauma syringe kit 4*1 ml 2*2 ml.This is report 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5 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, during an unknown procedure, the traumacem v+ injection cannula and traumacem v+ syringe kit would not inject into syringes once mixed.The procedure was successfully completed with no surgical delay.Patient outcome was unknown.

• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10508595
• MDR Text Key: 208149187
• Report Number: 2939274-2020-04054
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10886982262233
• UDI-Public: 10886982262233
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 03.702.150S
• Device Catalogue Number: 03.702.150S
• Device Lot Number: 8042526
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 09/30/2020
• Patient Sequence Number: 1