MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICROFIXATION FACIAL PLATING SYSTEM; 90 DEGREE CONTRA ANGLE SCREWDRIVER

Model Number N/A

Device Problems Device Inoperable (1663); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records shows the lot was released with no recorded anomaly or deviation.Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It is reported that during a right sided rib plating procedure on (b)(6) 2017, the driver made a clicking sound when the handle was turned and at a specific point in the rotation the surgeon was unable to continue turning the driver.The procedure was completed with a second contra-angle driver.The event did not cause an injury to the patient.There was approximately a five minute delay to the procedure.

Manufacturer Narrative

This report was submitted to correct the device product code and 510(k) number.

Event Description

This follow-up report is being submitted to relay corrected and additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.There is some friction and clicking sounds when rotating the knob and the rotating boss does not complete the rotation.The instrument was visually evaluated and found to be in poor overall condition.The driver has signs of wear and tear from use as well as discoloration throughout the body of the driver.The driver was disassembled for closer inspection.There was some discoloration found in the gearing of the device and the hex within the driver was found to be stripped.If enough torque is applied, the internal gearing can be overcome, which resulted in the stripping of the hex.Investigation results concluded that the reported event was due to excessive torque being applied.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: BIOMET MICROFIXATION FACIAL PLATING SYSTEM
• Type of Device: 90 DEGREE CONTRA ANGLE SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6774202
• MDR Text Key: 82057805
• Report Number: 0001032347-2017-00640
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• 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: 24-1189
• Device Lot Number: 999220
• Other Device ID Number: (01)00841036123130(10)999220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1