MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVS 2.7MM DIA DRL; BIT, DRILL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 09/21/2015

Event Type  Injury  

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.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, number 1 states, ¿surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.¿.

Event Description

It was reported that patient underwent initial total reverse shoulder arthroplasty on (b)(6) 2015.While drilling for the peripheral screws on the pmi baseplate, the tip of the drill fractured and as a result, the patient retained the tip of the drill.A new drill bit was opened to complete the operation, and the screws were inserted following the appropriate surgical technique.

Manufacturer Narrative

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

• Brand Name: COMP RVS 2.7MM DIA DRL
• Type of Device: BIT, DRILL
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 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: 5137171
• MDR Text Key: 27838005
• Report Number: 0001825034-2015-04227
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 405889
• Device Lot Number: ZB120303
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2012
• 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): Other