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

Model Number N/A

Device Problems Mechanical Jam (2983); Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the internal mechanism probably doesn't work properly, because if the user applies a little pressure on the internal plank, it moves instead of staying fixed.

Event Description

It was reported that the internal mechanism probably doesn't work properly, because if the user applies a little pressure on the internal plank, it moves instead of staying fixed.No adverse event has been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The reported event could not be confirmed.An investigation has been performed, consisting of a documentary review and a product analysis.The device has been returned to the manufacturer.The device analysis showed that the product worked as attended.The review of the device manufacturing quality record indicates that (b)(4) products designation optigun ratchet, reference (b)(4), lot number 0000699446 were manufactured on 12 january 2012.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.No other similar complaint was reported on the batch 0000699446 within one year.With the available information, the exact root cause of the event could not be determined.The documentary review showed that products were manufactured according to the pre-defined specifications of biomet france.The product analysis showed that the optigun 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.

• 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: 8459315
• MDR Text Key: 140139039
• Report Number: 3006946279-2019-00184
• 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: distributor,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 Model Number: N/A
• Device Catalogue Number: 4195
• Device Lot Number: 0000699446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 08/01/2019
• Supplement Dates FDA Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1