MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICROFIXATION THORACIC FIXATION SYSTEM; SCREW, 2.4X14MM

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 04/03/2015

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown; therefore the device history records are unable to be reviewed.The distributor reported this was the surgeon's first use of this system; multiple cases have been performed since this case without similar occurrences.No product evaluation could be performed as the product was not returned to the manufacturer.The most likely underlying cause of this complaint cannot be determined as this product was not returned.However, details provided by distributor indicate that the surgeons familiarity with the system as well as the patients condition could have contributed to the event.It is unknown how many screws or which part numbers were involved, therefore a report was submitted for each screw in the set.Report four of six for the same event, reference 1032347-2016-00364 through 1032347-2016-00369.This report is being submitted late as the team member who received the survey on april 5, 2015 failed to report it to the complaint team.The survey was identified on july 19, 2016 by a team member conducting post market surveillance activities.

Event Description

It was reported through a survey that several screws fell into the patient as a result of being knocked off by glancing tissue or bone if the tip of the screw did not make it to the plate hole unimpeded.It is reported the patient is obese, which added an additional challenge to reach and deliver screws through thick skin/tissue.The screws were removed using either fingers or forceps.It is also reported some screws would not seat all way using the right angle driver.The distributor confirmed in cases where the screws did not seat all the way they were firmly locked into the plate.There was no surgical delay or patient injury reported.

• Brand Name: BIOMET MICROFIXATION THORACIC FIXATION SYSTEM
• Type of Device: SCREW, 2.4X14MM
• 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: 5833552
• MDR Text Key: 50752440
• Report Number: 0001032347-2016-00367
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 76-2414
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR