MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SCREW SELF-DRILLING/LOCKING 2.4 X 10 MM; SCREW, FIXATION, BONE

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.A picture of the x-ray was provided confirming the plate fracture.The lot number is unknown; therefore the device history records are unable to be reviewed.The warnings in the package insert state, "the patient is to be instructed in the use of external supports and braces that are intended to immobilize the site of the fracture or other non-union and limit load bearing.The patient is to be made fully aware and warned that the device does not replace normal healthy bone, and that the device can break, bend or be damaged as a result of stress, activity, load bearing or inadequate bone healing." based on the information available the most likely cause is due to the patient not following post operative instructions.If additional information is obtained that adds value to the relevant content of this report a follow-up report will be sent.The screw part numbers were identified through a purchase requisition document provided by the distributor on may 4, 2017.Therefore, this will be report three of six for the same event.Reports one, two, and four through six are reported on mfr #0001032347-2017-00177, 0001032347-2017-00178, and 0001032347-2017-00433 through 0001032347-2017-00435.

Event Description

The patients left ribs 4-9 were plated on (b)(6) 2016.It was reported the patient fell on (b)(6) 2017 was admitted with chest wall pain.It is reported the plate broke on rib 7, rib 6 the screws pulled out of the anterior segment of rib, and rib 9 the rib fractured longitudinally around all of the screws used to keep it in place.It is confirmed that no re-operation has occurred because the patient did not comply and did not follow up with the surgeon.

Manufacturer Narrative

The product identity of the fractured plate was confirmed through the 3-d scan provided.The product identity of the screws could not be confirmed because no product was returned and the screws could not be identified through the scan provided.The surgeon provided a 3-d scan.A review of the scan shows one rib that has a displaced fracture and a fractured plate that is still fixated to the rib on both sides of the rib fracture.The fractured plate has two empty screw holes on the end and appears to be coming off the bone.Another rib has what appears to be a comminuted fractured, which would cause the screws to loose purchase.The complaint is confirmed.The most likely underlying cause of this complaint is determined to be trauma experienced by the patient as the result of a fall.There are no indications of manufacturing defects.This is report three of six for the same event.Reports one, two, and four through six are reported on mfr #0001032347-2017-00177, 0001032347-2017-00178, and 0001032347-2017-00433 through 0001032347-2017-00435.

• Brand Name: RIBFIX BLU SCREW SELF-DRILLING/LOCKING 2.4 X 10 MM
• Type of Device: SCREW, FIXATION, BONE
• 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: 6597503
• MDR Text Key: 76156803
• Report Number: 0001032347-2017-00432
• 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,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Device Unattended
• Device Model Number: N/A
• Device Catalogue Number: 76-2410
• 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: 05/26/2017
• 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: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1