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 07/10/2021

Event Type  malfunction  

Manufacturer Narrative

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, 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2021 the surgeon had planned to use traumacem v+ to augment trochanteric fixation nail-advanced (tfna) blade.During the surgery after completing the fixation of the tfna blade, the cannula was used to check for leakage using omnipaque contrast solution.After that the traumacem v+ cement was prepared as per recommended techniques, but the cement did not come out and the augmentation couldn't be performed.The surgeon had successfully performed this procedure earlier also so he is suspecting there was some issue with the cement kit.There was a unspecified amount of surgical delay.This report is for one (1) traumacem(tm) v+ syringe kit - sterile.This is report 2 of 2 for complaint (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.H3, h4, h6: part # 03.702.150s, lot # 0112747, manufacturing site: selzach, supplier : (b)(4), release to warehouse date: 11 dec 2020, expiry date: 01 dec 2025.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.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: h3, h6: part: 03.702.150s, lot: 0112747, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 11 december 2020, expiry date: 01 december 2025.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the trauma syring kit 4*1 ml 2*2 ml.No cement was found on or in the trauma syring kit 4*1 ml 2*2 ml.The legal manufacturer of the device was notified of the complaint and did not investigate as the allegation was against the cement, but the needle kit.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the trauma syring kit 4*1 ml 2*2 ml was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: 12291194
• MDR Text Key: 265582615
• Report Number: 8030965-2021-06509
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 07/10/2021

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: 0112747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 09/30/2021; 07/27/2022
• Supplement Dates FDA Received: 09/30/2021; 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TRAUMA NEEDLE KIT Ø3.3 CANNUL W/SIDE-OPE; TRAUMACEM V+ CEMENT KIT 10 ML