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

Catalog Number 4195

Device Problems Mechanical Jam (2983); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, [device malfunction].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Lot number not communicated.

Event Description

It has been reported that it was not possible to press the cement out when cylinder was put in the gun.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : e1-g1-2, g4, h2, h6, h10.The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record could not be reviewed as the lot number of the product were not communicated.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 was reported that it was not possible to press the cement out when cylinder was put in the gun.

• Brand Name: OPTIGUN RATCHET
• 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: 8389643
• MDR Text Key: 137860710
• Report Number: 3006946279-2019-00141
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 07350023771603
• UDI-Public: (01)07350023771603
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4195
• Device Lot Number: NOT COMMUNICATED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1