MAUDE Adverse Event Report: BIOMET MICROFIXATION IMF SCREW; BONE SCREW

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/03/2014

Event Type  Injury  

Event Description

It was reported that one imf screw broke during surgery and the tip of the screw was retained in the patient's bone.

Manufacturer Narrative

Device return anticipated but not yet received.Without a known part and lot number, review of the manufacturing records cannot be performed.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.

Manufacturer Narrative

The returned screw was evaluated for the complaint that it broke during surgery and the tip remained in the patient¿s bone.Upon evaluation the complaint was confirmed as the screw was fractured through the minor diameter of the threads.There was no indication of manufacturing defects.The most likely cause of the complaint issue is excessive torque applied by the user.The risk of the screw breaking is captured in the application fmea for ¿imf screw systems¿ under #6/screw insertion/affix screws to bone/screw breaks.The listed severity is a ¿3¿ and the occurrence is a ¿1¿ which from sop4.1.1 is ¿modification to surgical procedure, major increase in surgical time¿ and ¿=.5%¿.The surgery delay did not exceed thirty minutes, the patient retained a foreign body but no other adverse effects were reported.The severity of this complaint is no greater than the severity listed in the fmea.For this part (91-5611) and the previous two (2) years (from the notification date), this has been the only complaint regarding the screw not fixating.(b)(4).There are no updates to the risk documents needed.

• Brand Name: IMF SCREW
• 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: amanda sisk ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 3959623
• MDR Text Key: 4560348
• Report Number: 0001032347-2014-00225
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK983728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• 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: 91-5611
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2014
• 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): Disability