MAUDE Adverse Event Report: SYNTHES GMBH TRAUMACEM(TM) V+ SYRINGE KIT - STERILE; DISPENSER, CEMENT

Catalog Number 03.702.150S

Device Problem Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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 history lot: part: 03.702.150s, lot: 1022578, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: march 23, 2021, expiration date: february 01, 2026.A manufacturing record evaluation was performed for the finished article lot and no non-conformance's 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for the femoral neck fracture with the cement and cement injection cannula in question.10years before this surgery, the patient underwent the osteosynthesis surgery for femoral neck fracture and the implants had been removed on an unknown date.The surgery was completed successfully within 30minutes delay.No further information is available.Concomitant device reported: unk: impaction instruments: hammer/mallet: trauma: (part# unknown; lot# unknown; quality:1).This complaint involves (4) devices.This report is for (1) traumacem(tm) v+ syringe kit - sterile.This report is 2 of 3 for (b)(4).

• Brand Name: TRAUMACEM(TM) V+ SYRINGE KIT - STERILE
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 12289377
• MDR Text Key: 265465138
• Report Number: 8030965-2021-06488
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 07611819476523
• UDI-Public: (01)07611819476523
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.702.150S
• Device Lot Number: 1022578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TRAUMACEM V+ CEMENT KIT 10 ML; TRAUMACEM V+ INJECTION CANNULA TFNA -S