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

Catalog Number 03.702.150S

Device Problem Break (1069)

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

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received, the investigation is in progress, 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation surgery for the proximal femoral trochanteric fracture with the traumacem injection cannula and traumacem syringe kit.During the surgery, when the surgeon inserted the 1ml cement to the cannula through the syringe, the cement couldn¿t be inserted even though the cement had not hardened.It seemed that the tip of the syringe was broken.The surgery was completed successfully within thirty (30) minutes delay.Patient outcome is reported as stable.No further information is available.Concomitant device reported: traumacem(tm) v+ injection cannula for tfna - sterile (part # 03.702.121s, lot # atm860, quantity 1).This report is for one (1) traumacem(tm) v+ syringe kit - sterile.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.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: visual inspection has shown that the two received parts are in the following condition.Part 1: the luer tip of the sample 1 is broken.The luer threads at the bottom are damaged which could be indicated that the screwing has been forced.As the luer lock of the sample is damaged, we can't control the dimensional conformity.Part 2: the luer of the sample 2 is not damaged.Dimensional inspection: the control has been performed according to specification, all measurements done could be confirmed.Document/specification review: the batch file review show that the products were manufactured, controlled and released in accordance with symatese device procedures and specifications.No anomaly or deviation in relation with the complaint, was reported during the manufacturing of the lot.Summary: according to the investigation above and the samples analysis, the potential cause identified is probably due to a screwing 'too hard' to the bottom of threads.By screwing 'too hard', there is a risk of breaking the luer tip and blocking the luer.The design of the syringe can't limit screwing torque.The batch number is compliant to synthes specification.As the batch is compliant to specification and the occurrence is very low, no corrective action is planned.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.702.150s, lot: 0072555, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 26.Aug.2020, expiry date: 01.July 2025.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.H10 additional narrative: d9: received (2) two trauma syringe kit 4*1 ml 2*2 ml part 03.702.150s and lot 0072555.H3, h6: the device was received, the investigation is in progress, 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.

• Brand Name: TRAUMACEM(TM) V+ SYRINGE KIT - STERILE
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11118507
• MDR Text Key: 226105652
• Report Number: 8030965-2021-00062
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 07611819476523
• UDI-Public: (01)07611819476523
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2020

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 Catalogue Number: 03.702.150S
• Device Lot Number: 0072555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 01/12/2021; 03/03/2021
• Supplement Dates FDA Received: 02/01/2021; 03/04/2021
• Patient Sequence Number: 1