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

Catalog Number 419300

Device Problems Device Slipped (1584); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2019

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 cement gun is slipping at the point where approximately 85% off the cement has been ejected from the cement tube.

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 device has been returned to the manufacturer.The device analysis showed that the product works as attended.According to available data, the exact root cause can¿t 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.

Event Description

It has been reported that the cement gun was slipping at the point where approximately 85% off the cement has been ejected from the cement tube.Therefore the surgeon was not able to utilize all of the cement.No adverse patient consequences have been reported.

• 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: 8522447
• MDR Text Key: 142350451
• Report Number: 3006946279-2019-00241
• 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
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

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: 419300
• Device Lot Number: 655433012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 08/01/2019
• Supplement Dates FDA Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1