MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIVAC M; MANUAL ORTHOPAEDIC CEMENT MIXER, REUSABLE

Catalog Number 4160

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that during the application of cement into a patient's femoral canal, at the point of snapping off the cement applicator nozzle, the whole length of the applicator cartridge nozzle snapped and broke.An attempt was made to reconnect the nozzle to cement applicator cartridge.However, on inspection, the two connections were broken.As some cement has already been applied to the patient's femoral canal, the consultant decided to proceed and improvise the rest of the application of cement.No known adverse event was reported.

Event Description

It was reported that during the application of cement into a patient's femoral canal, at the point of snapping off the cement applicator nozzle, the whole length of the applicator cartridge nozzle snapped and broke.An attempt was made to reconnect the nozzle to cement applicator cartridge.However, on inspection, the two connections were broken.As some cement has already been applied to the patient's femoral canal, the consultant decided to proceed and improvise the rest of the application of cement.No known adverse event was reported.

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.A complaint extract was done regarding nozzle damaged: 1 complaint (1 product), this one included, has been recorded on optivac m, reference (b)(4), from 01 (b)(6) 2018 to (b)(6) 2022.1 complaint (1 product), this one included, has been recorded on optivac m, reference (b)(4), batch 0001538624.Investigation results concluded that the product is conform and the root cause is undetermined.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: OPTIVAC M
• Type of Device: MANUAL ORTHOPAEDIC CEMENT MIXER, REUSABLE
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12672467
• MDR Text Key: 280092036
• Report Number: 3006946279-2021-00182
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4160
• Device Lot Number: 0001538624
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1