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

Catalog Number 4195

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

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 during preparation for surgery the optigun has malfunctioned.

Event Description

It was reported that during the preparation of the surgery the function of the optigun was tested successfully.The bone cement was mixed in the optipac-system as intended.But during the surgery the cement could not be pushed out.The toothed rack of the cement gun could not be pushed forward due to moving the handle.Therefore the cement had to be discarded and there was a delay of 10 minutes.The product was used for the first time.The surgery was finished with an other mixing system (palamix).No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5, d10, e1, g4, h2, h3, h4, h6, h8, h10.Complaint sample was evaluated and the reported event was confirmed.The returned device evaluation shows that the product it seemed to be in good condition in terms of appearance.However, it was noted on the handle that there was a piece of spring coming out of the handle.We also noticed that there was missing a pin supposed to hold the spring to make the optigun work as intended.The pin is not there so the optigun does not work.The review of the device manufacturing quality record indicates that (b)(4) products designation optigun ii, reference (b)(4), lot number 690633012 were manufactured on 06 march 2019.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 complaint on the issue has been recorded for optigun ii, reference (b)(4), lot number 690633012 within one year.An investigation has been performed, consisting of a documentary review and a product analysis.The documentary review showed that products were manufactured according to the pre-defined specifications of biomet france.According to available data, the exact root cause of the event 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: 8645506
• MDR Text Key: 146233969
• Report Number: 3006946279-2019-00268
• 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: 10/17/2019

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: 690633012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1