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

Catalog Number 906063

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of repair records received from supplier. The device was returned to supplier. Visually the device is ok, broken lanyard. Corrosion in connector end, buttons don't work, won't run/motor frozen, fails hi-pot on step 2-4, cable passes hi-pot. The motor, flex strip, seals, and all o-rings were replaced and the device was tested per procedure. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required. Root cause was determined to be bad motor, rust and corrosion (not related to manufacturing or design). If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

During a procedure, the shaver attachment did not work. There was no harm to the patient or operator. Surgery was not delayed due to this malfucntion.

• Brand Name: POWERTEK II PLUS HP ONLY
• 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: 6215403
• MDR Text Key: 130230347
• Report Number: 0001825034-2016-05469
• 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: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/21/2017

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 Catalogue Number: 906063
• Other Device ID Number: N/A
• 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: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NI