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

Catalog Number 4195

Device Problems Partial Blockage (1065); Defective Component (2292); Mechanical Jam (2983); Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Batch number not communicated.

Event Description

It has been reported that the surgeon had commenced cementing and, whilst cementing, the ratchet gun ceased working half way through cementing.This event caused a brief delay in the completion of the cementing process.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

(b)(4).The device manufacturing quality record could not be reviewed as it was not possible to retrieve the lot number of the product.Complaint sample was evaluated and the reported event could not be confirmed.The returned product worked well when the trigger was activated.According to the available data, the most probable root cause is a handling error.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 surgeon had commenced cementing and whilst cementing, the ratchet gun ceased working half way through cementing.This event caused a brief delay in the completion of the cementing process.

• 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: 7517505
• MDR Text Key: 108374318
• Report Number: 3006946279-2018-00162
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2019

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: 4195
• Device Lot Number: NOT COMMUNICATED
• Other Device ID Number: (01) 07350023771603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 04/17/2018; 01/29/2019
• Supplement Dates FDA Received: 09/05/2018; 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1