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

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2019

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 was reported that the user was unable to retract the handle from the optigun.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay correction information.The following section has been updated : b5, d2, d4, d10, e3, g3, g4, h2, h3, h4, h6, h10.Complaint sample was evaluated and the reported event was confirmed.The product was returned and lab analysis was performed.The returned item has been inspected according to an internal checklist, as part of our documentation process, which describes the different items to review.The handle didn¿t function as intended, it doesn¿t return to the starting position.The product was washed in an ultrasonic machine with water and soap.Once finished a tensile test on the optigun was performed and the optigun was working again.One hypothesis is that there were debris trapped in the handle.The review of the device manufacturing quality record indicates that (b)(4) products optigun ratchet reference 4195, batch number 546689012 were manufactured on 18 april 2016.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.One complaint has been recorded for have been recorded for optigun ratchet, batch 546689012 within one year.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation was sent to the complainant.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 was reported that the user was unable to retract the handle from the optigun.No adverse event was reported.

• Brand Name: OPTIGUN RATCHET
• Type of Device: ORTHOPAEDIC CEMENT DISPENSER
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8753957
• MDR Text Key: 149817663
• Report Number: 3006946279-2019-00303
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 07350023771603
• UDI-Public: (01)07350023771603
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• 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: 4195
• Device Lot Number: 546689012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1