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 11/08/2021

Event Type  malfunction  

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 osteosynthesis surgery.After insertion of the blade, cement was prepared.The surgeon started mixing operation by placing monomer liquid into a cartridge without spilling it.The surgeon turned a handle clockwise and stroked about 40 times.The valve was in a slightly elevated position during the stroke.Only 6.5 ml of cement in total was filled in white and blue syringes.The surgeon injected the cement to the bone head of femur according to the surgical technique, but the cement flow from a blade could not be monitored by image intensification.When the surgeon checked after injecting cement again, the surgeon found that cement flowed into the fracture site.When a cannula was inserted again, it was not fully inserted, so a sleeve was removed, and the cannula was inserted directly into the blade.Then, when the remaining cement was injected, it was confirmed that a small amount of cement flowed out from the blade.Therefore, the surgeon inserted a locking screw and endcap and completed the procedure.There was no surgical delay.After the surgery, the surgeon and the sales rep checked the cannula, blade (sample implant), sleeve, but there was no defect on them, and there was no leak of cement inside the sleeve.No further information is available.This report is for one (1) traumacem(tm) v+ syringe kit - sterile.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

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.H6: a device history record (dhr) review was conducted: part# 03.702.150s.Lot# 1012515.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 23 february 2021.Expiry date: 01 january 2026.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.

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: all medical device reports associated with the same/similar device(s) and reported condition of ¿unable to transfer¿ were reviewed.It was determined that ¿unable to transfer¿ has not caused or contributed to any serious injuries or deaths within the reviewed time period of (b)(6) 2019- (b)(6) 2022.Based on the reviewed data, the likelihood of a death or serious injury occurring as a result of ¿unable to transfer¿ is remote; therefore, ¿unable to transfer¿ associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.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): 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12940727
• MDR Text Key: 286650691
• Report Number: 8030965-2021-09986
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• 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: 1012515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TFNA HELICAL BLADE PERF L85 TAN; TRAUMA NEEDLE KIT Ø3.3 CANNUL W/SIDE-OPE; TRAUMACEM V+ CEMENT KIT 10 ML