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

Catalog Number 4193

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.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.

Event Description

It has been reported that the gun gears skipped and the cement could not advancing.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5, d10, g1-2, g4, h2, h3, h6, h10.The reported event could not be confirmed.An investigation has been performed, consisting of a documentary review and a product analysis.The product analysis shows that the optigun works as attended.The documentary review showed that products were manufactured according to the pre-defined specifications of biomet france.No similar complaint was recorded on the same batch.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 gun gears skipped and the cement could not advance.No adverse events have been reported as a result of the malfunction.

• Brand Name: 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: 8428051
• MDR Text Key: 139092732
• Report Number: 3006946279-2019-00176
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 07350023771146
• UDI-Public: (01)07350023771146
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4193
• Device Lot Number: 665525012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1