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

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

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.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.Lot number not communicated.

Event Description

It has been reported that cement gun does not advance beyond approximately 70% resulting in a shortage of cement for implantation.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The product was not returned so the event could not be confirmed.The product analysis can't be performed as the product was not returned.The review of the device manufacturing quality record indicates that 30 products scandimed optigun ii, reference: (b)(4), batch: 655433012 were manufactured on 24th august 2017.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.2 similar complaints have been recorded for scandimed optigun ii, batch: 655433012 within one year.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.

Event Description

It has been reported that cement gun does not advance beyond approximately 70% resulting in a shortage of cement for implantation.The surgery was completed with another product.No known adverse event was reported.

• Brand Name: SCANDIMED OPTIGUN II
• 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: 8619297
• MDR Text Key: 145505564
• Report Number: 3006946279-2019-00265
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 0880304371019
• UDI-Public: (01)0880304371019
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• 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: 419300
• Device Lot Number: 655433012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1