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 08/03/2016

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

During a procedure, the arthroscope powerpump would not properly function.Another device was used to complete the procedure without delay.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of repair work order documentation from the supplier.Review of the dhr indicates this device was previously repaired.The motor was non-functional/non-responsive.Inside of device was packaged with contamination and irrigation path was clogged.The motor was replaced as well as damaged spacers, seal head, face seal, and all o-rings.Device was cleaned, reassembled and tested per then-current procedures.Device was returned to supplier for a second time and examined.Corrosion was noted in connector end.Cable outer casing is cracked in several places.The device fails current draw testing.The shaft face has lifted surface.The cable, motor, seal, and all o-rings were replaced and device tested per procedure.Review of the complaint history determined that no further action(s) is/are required.Investigation results concluded that the reported event was due to bad motor, corrosion and damaged cable.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: 6215798
• MDR Text Key: 63653006
• Report Number: 0001825034-2016-05522
• 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,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 906063
• Device Lot Number: 084820
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2015
• 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