MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5 X 4 MM HIGH TORQUE SELF-DRILLING CROSS-DRIVE SCREW 5-PACK; SCREW, FIXATION, BONE

Model Number N/A

Device Problems Fracture (1260); Difficult to Insert (1316); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

Review of the device history records show that the lot was 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.Without a product return, no product evaluation is able to be conducted.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 #0001032347-2017-00096.

Event Description

It is reported two screws broke and one became worn during surgery.More information was requested and has yet to be received.

Manufacturer Narrative

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.This is report two of two for the same event.Report one of two is reported on mfr #0001032347-2017-00096-1.

Event Description

(in addition to what was already reported) it is reported the portion of the broken screw did not fall into the patient.This event did not cause a delay.The surgeon completed the surgery using another screw with the same part number.

Manufacturer Narrative

The product identities were confirmed in the evaluation.The screws were visually evaluated.The complaint is confirmed for having 2 screws broken and 1 screw slightly worn.All screws were functionally tested.One of the broken screws could not be retained by the driver.The other two screws could support the weight of the driver.Out of the two screws that had retention, only the non broken screw was able to be properly inserted.The most likely underlying cause of the broken screws was determined to be excessive force.The most likely underlying cause of the worn screw cannot be determined as the screw was successfully able to be inserted into white oak and had proper retention.This is report two of two for the same event.Report one of two is reported on mfr #0001032347-2017-00096.

• Brand Name: 1.5 X 4 MM HIGH TORQUE SELF-DRILLING CROSS-DRIVE SCREW 5-PACK
• 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: 6327239
• MDR Text Key: 67294754
• Report Number: 0001032347-2017-00097
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• 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: 95-6104
• Device Lot Number: 979780
• Other Device ID Number: (01)00841036086650(10)979780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• 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
• Patient Outcome(s): Required Intervention