MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. SCANDIMED OPTIGUN II; DISPENSER, CEMENT

Catalog Number 419300

Device Problems Defective Device (2588); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that surgeon was attempting to extrude cement from optipac tube.While squeezing the trigger in the proper manner the piston would not advance and the result was that the cement would not eject from the delivery nozzle.

Event Description

It has been reported that the surgeon was attempting to extrude the cement from the optipac tube.While squeezing the trigger in the proper manner, the piston would not advance and the result was that the cement would not eject from the delivery nozzle.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The product analysis shows that the optigun works as attended.With the available information, the exact root cause of the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SCANDIMED OPTIGUN II
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8398300
• MDR Text Key: 138427685
• Report Number: 3006946279-2019-00166
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 0880304371019
• UDI-Public: (01)0880304371019
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 419300
• Device Lot Number: 585669012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1