MAUDE Adverse Event Report: BIOMET MICROFIXATION CANCELOUS LOCKING SCREW 2.4 X 14 MM; BONE SCREW

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 11/18/2016

Event Type  Injury  

Manufacturer Narrative

A review of the device history records show the lot released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore a facility medwatch report will not be available.It is reported the patient's bone density was very high.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report two of two for the same event; report one of two is reported on mfr #0001032347-2016-00784.

Event Description

It was reported that during an aneurysm dissecting procedure for the body of the sternum, screws could not be completely inserted and had to be backed out by the surgeon.It is reported the surgeon tried using a manual driver after he couldn't insert the screws with the power driver.However, the screws still would not insert into the bone with the manual driver.It is reported the surgery was completed with less than a ten minute delay.It is reported that new screws of a smaller size were used in the same holes to complete the surgery.

Manufacturer Narrative

The product identities were confirmed through a picture provided by the distributor.Review of the picture reveals blood on the bent screws.This is consistent with the distributor's report that there were insertion attempts and the surgeon applied significant force to attempt to further insert the screws.Beyond the screws being bent, it does not appear to be any further damage on the screws' heads or threads.The distributor reported the screws were discarded.No product was returned and no functional tests could be performed; therefore the complaint could not be verified.The distributor stated the patient's bone density was very high.The most-likely underlying cause of this complaint is patient condition.There are no indications of manufacturing defects.This is report two of two for the same event.Report one of two is reported on mfr #: 0001032347-2016-00784-1.

• Brand Name: CANCELOUS LOCKING SCREW 2.4 X 14 MM
• Type of Device: BONE SCREW
• 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: 6214289
• MDR Text Key: 63588263
• Report Number: 0001032347-2016-00785
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK110574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-2414
• Device Lot Number: J244410
• Other Device ID Number: (01)00841038141158(10)J244410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• 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