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 Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient information was not provided for reporting.Device is an instrument and is not implanted / explanted.(b)(4).The device was received and the product evaluation is in progress.No conclusion can be drawn.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 report that the patient underwent original surgery on (b)(6) 2018 for treatment of a femur fracture.Patient was implanted with one (1) tfna trochanteric fixation nail advanced, (1) helical blade and two (2) distal locking screws.Intraoperatively, after the nail had been implanted, at the back table, that surgeon prepared the ttaumacem v cement.It was reported that the injector was not filling the syringes initially.It would not turn properly, and the hole where the stop connects was trapped.The doctor cleared the hole, that was jammed, and pmma slowly released into syringes.By this time the viscosity was too thick to send down injection cannula.Surgeon was unable to inject the cement mix through to the helical blade implant.Surgeon chose not to include the cement mix that was ordinally planned for in this procedure.Surgery was completed successfully with 5-minute time delay.Patient was reported in stable condition.Concomitant device reported: traumacem (tm) v+ injection cannula for tfna - sterile (item # 03.702.121s, lot # aqy317, quantity 1).This report is for one (1) traumacem(tm) v+ syringe kit - sterile.(b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Part 03.702.150s, lot 7032671: manufacturing location: (b)(4).Supplier: (b)(4) device.Release to warehouse date: (b)(6) 2017.Expiry date: february 28, 2022.No non-conformance reports (ncrs) were generated during production.Review of the device history records (dhr) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: all received single syringes (4 × blue 1 ml syringes and 1 × white 2 ml syringes) were used during surgery and partially filled with cured cement and a functional test therefore cannot be conducted.During the cement preparation the traumacem v+ cement kit is used to fill single syringes (blue 1 ml syringes and white 2 ml syringes).The reported event problem describes the event to be caused in the traumacem v+ cement kit because of cement transfer problems.Per the technique guide, various circumstances may result in cement transfer problems.However, it is very unlikely that the reported trauma syringe kit led to the reported problem.With the available information we are not able to determine the cause of the reported problem.The dhr review shows that the production procedure was according to the specifications at the manufacturing time in july 2017 and there were no issues that would contribute to this complaint condition.A device history record (dhr) review and device inspection were performed as part of this investigation.The complaint condition is unconfirmed as no issue was identified with the syringes.Cured cement was observed in the syringes but the cement is from the cement kit.Dimensional/drawing review is not relevant as the issue is related to the cured cement from the mating device.Replication of the complaint condition is not applicable as the material has already cured.No ncrs were generated during production.The cement kit lot went through the required steps during the inspection at the time of manufacturing and the dhr records showed no issues concerning the material or manufacture of the kit components.With the available information, no product issues or defects were identified with the available single syringes.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
• 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: 7321120
• MDR Text Key: 101772406
• Report Number: 2939274-2018-50916
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10886982262233
• UDI-Public: (01)10886982262233(17)EXPIRATIONDATEUNKNOWN(10)7032571
• 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,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 03.702.150S
• Device Catalogue Number: 03.702.150S
• Device Lot Number: 7032671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention