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

Catalog Number 03.702.150S

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/25/2021

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 on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for trochanteric femur fracture with the syringe and cannula in question.When filling the white syringe after cement mixing, the surgeon was squeezing it with a very strong force (there was a slight sound), so the sales representative who was present at the surgery advised them not to exert too much force.Four blue syringes and two white syringes were filled with cement, and when the surgeon tried to fit the blue syringes into the cannula, the thread part did not fit.When the surgeon checked after wiping off the leaked cement at the cannula connection part, the tip protrusion on the internal thread of the syringe was broken and remained stuck in the entrance on the cannula side.The surgeon tried to inject the cement into the body after transferring cement from the other syringe into the broken white syringe, but only about 1 ml of cement could be injected.During the operation, the sales rep told the surgeon that the other doctors did not tighten forcefully when filling the syringe in the cases at other facilities, but this surgeon emphasized because he was concerned about the loose connection between the cannula and the syringe.Procedure was completed successfully within thirty(30)minutes delay.After surgery, the sales rep also witnessed the same surgery at another hospital and confirmed that there was no leakage of cement by adjusting the force even if the connection between the cannula and the syringe was loose.The sales rep explained this content to the surgeon and had him understand it.The doctor commented that he would be more careful in the future.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: part # 03.702.150s; lot # 1022696; manufacturing site: selzach; release to warehouse date: 08 mar2021; expiration date: 01 mar2026; supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that trauma syring kit 4*1 ml 2*2 ml the cement was solidified, and the tip and the syringes were broken, and no other issues were identified.The dimensional inspection was not performed due to alleged complaint condition.Since the surgeon has used the excessive force the alleged complaint is cause trace to the user.The observed condition of trauma syring kit 4*1 ml 2*2 ml in the device was consistent with the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for trauma syring kit 4*1 ml 2*2 ml.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot 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.Drawing/specifications reviewed? the following drawing reflecting the current and manufacture revision was reviewed: trauma syringe kit, 4 x 1ml, 2 x 2ml.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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12525876
• MDR Text Key: 273120508
• Report Number: 8030965-2021-07961
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

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: 1022696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• Is the Device Single Use?: No
• 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.; TRAUMA NEEDLE KIT Ø3.3 CANNUL W/SIDE-OPE; TRAUMACEM V+ CEMENT KIT 10 ML