MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE POWERTEK II PLUS SHAVER ARTHROSCOPE

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

Prior to the start of a procedure, the arthroscope powerpump would not properly function. Subsequently, the procedure was delayed to another day.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information. Upon reassessment of the reported event, it was determined to be not reportable as this component was discovered to be malfunctioning prior to a procedure and did not cause serious injury. Additionally, the exact malfunction is unknown. The initial report should be voided.

• Brand Name: POWERTEK II PLUS SHAVER
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6215799
• MDR Text Key: 63653413
• Report Number: 0001825034-2016-05518
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: PK020761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 906063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Removal/Correction Number: N/A