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 11/04/2021

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 open reduction internal fixation surgery for trochanteric fracture of femur.In the surgery, the stopcock broke because the surgeon turned a blue syringe attached to the stopcock with excessive force.The surgery was completed with no surgical delay.The patient condition was stable.This complaint involves one (1) device.This report is for (1) traumacem(tm) v+ syringe kit - sterile.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.Initial reporter information unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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: all medical device reports associated with the same/similar device(s) and reported condition of ¿broken" were reviewed.It was determined that ¿broken" 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 ¿broken" is remote; therefore, ¿broken" 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12917166
• MDR Text Key: 281605631
• Report Number: 8030965-2021-09894
• 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: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.702.150S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1