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

Catalog Number 419300

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.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that there is a stripped screw on the handle of the cement gun.

Event Description

It was reported that there is a stripped screw on the handle of the cement gun.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 correction information.Reported event was confirmed by the review of the product.When the product was received it seemed to be in good condition in terms of appearance but a little old.Everything seems to work normally on the product however 2 screws were found stripped on the handle of the optigun.The review of the device manufacturing quality record indicate that (b)(4) products désignation optigun ii, reference (b)(4), batch 0000752227 were manufactured on august 21, 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 complaint issue (complaint category "device malfunction") event described in the complaint.No other similar complaint has been recorded for optigun reference (b)(4), lot 0000752227 within one year.According to the available data, the most probable root cause is due to wear.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.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: SCANDIMED OPTIGUN
• 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: 8619507
• MDR Text Key: 145387112
• Report Number: 3006946279-2019-00263
• 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: 10/21/2019

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 Catalogue Number: 419300
• Device Lot Number: 0000752227
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1