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 11/28/2015

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 shaver attachment of the arthroscope powerpump would not properly function.Another device was used to complete the procedure without delay.

Manufacturer Narrative

Reported event was confirmed by review of supplier repair records.The device was returned to the supplier.The device visually looked good.The device runs ok, reverse button does not work, vacuum tube is loose and bent.Valve is loose (o-rings worn), some corrosion on pins in connector in.Motor fails hi-pot test on step 2-4, no tvs present.The motor, flex strip, seals, and all o-rings were replaced and 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(s) is/are required.Investigation results concluded that the reported event was due to low resistance in motor 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.

• 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: 6215373
• MDR Text Key: 63619123
• Report Number: 0001825034-2016-05524
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was 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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 906063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2015
• 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