MAUDE Adverse Event Report: BIOMET TRAUMA T7 DRIVER CANN AO; INSTRUMENT, MANUAL

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.(b)(4).This report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2016-03390 / 03391).Device requested, not yet received.

Event Description

During a procedure, the screwdriver warped while tightening a screw.Another screwdriver was used to complete the procedure without delay.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.(b)(4).The twisted driver was returned for evaluation, and the complaint was thus confirmed.No applicable dimensional analysis could be completed with the damage to the instruments.Review of the manufacturing records identified this device was released for distribution with no deviations or anomalies.The device was determined to be conforming to print specifications as a result of this review.This device is used for treatment.Investigation has determined that the root cause for this event is attributed to the design of the device.Corrective action has been initiated for the reported issue of this device.

Manufacturer Narrative

The 510k number was added.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

• Brand Name: T7 DRIVER CANN AO
• Type of Device: INSTRUMENT, MANUAL
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5917229
• MDR Text Key: 53570545
• Report Number: 0001825034-2016-03390
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK142658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110018531
• Device Lot Number: 14042A
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1