MAUDE Adverse Event Report: SYNTHES MONUMENT DELIVERY NEEDLE 10GA X 10CM-STERILE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number DLS-7103-01S

Device Problems Delivery System Failure (2905); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

Patient age or date of birth and weight not available for reporting.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Used to capture change to surgical plan (competitor¿s product used to complete procedure).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

It was reported that the norian drillable inject would not come out of the pouch into the syringe (delivery needle) during a tibia plateau procedure on (b)(6) 2017.While at the back table, the norian had been mixed and would not come out of the pouch which caused a five-minute surgical delay.Intraoperative routine x-rays were taken.A competitive product was used to complete the procedure successfully.Patient reported as stable.It is unknown if the issue was with the norian drillable inject or the syringe (delivery needle).This report is for one (1) delivery needle 10 ga x 10 cm.This is report 2 of 2 for (b)(4).

• Brand Name: DELIVERY NEEDLE 10GA X 10CM-STERILE
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6998324
• MDR Text Key: 90940835
• Report Number: 1719045-2017-11130
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DLS-7103-01S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention