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

Model Number N/A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

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.

Event Description

It was reported that, when squeezed, the handle does not return to the original position; it is as if the spring was not strong enough.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay correction information.The following section has been updated : description of event or problem, concomitant medical products, premarket identification, type of report, follow up type, device evaluated by mfr, adverse event problem, additional mfr narrative.Reported event was confirmed as the product was returned.The product has been inspected and it can be observed that the handle malfunction.Indeed, it does not return to the original position every time.However as, the malfunction is not continuous, the optigun can be used.The review of the device manufacturing quality record indicates that 10 products optigun ratchet, reference 4195, lot number 670171012 were manufactured on (b)(6) 2018, 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.Only this complaint has been recorded for optigun, batch 670171012 within one year.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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, when squeezed, the handle does not return to the original position; it is as if the spring was not strong enough.The instrument was never used in theater, just tested after being removed from the box.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.With the available information, the exact root cause of the event could not 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, when squeezed, the handle does not return to the original position; it is as if the spring was not strong enough.

• 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: 8231737
• MDR Text Key: 132577694
• Report Number: 3006946279-2019-00018
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• 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: 670171012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1