MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POWERTEK II PLUS SHAVER HANDPIECE ARTHROSCOPE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). Device returned to supplier/manufacturer for evaluation and repair. The reported event is confirmed. Product was returned to the supplier for evaluation and repair. The visual inspection identified that the anodize appeared lighter than usual. It was alo noted that the hand piece runs forward but not in reverse. A lot of moisture was noted at the end of the motor and on top of the bearing. The appearance of the housing indicated that the anodize surface was coming off. The motor, housing, shaft face, threaded insert, tvs, housing, buttons, all seals, o-rings, and flex strip were replaced and tested per procedure. Maintenance review of the device indicates that it has not been previously repaired. Review of the complaint history determined that no further action is required. A definitive root cause was attributed to the moisture getting past the worn o-rings and seals, or the motor being worn from use, or both. No corrective actions, preventive actions, or field actions resulted after investigation of this event. 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

(b)(4). Report source: foreign: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. The information provided on this form was previously submitted under manufacturing report number 0001825034-2017-08285.

Event Description

It was reported that at the beginning of an unknown procedure, this device did not work. The surgery was delayed for 50 minutes while exchanging the device with another one. The surgery was completed and no other adverse events have been reported at this time.

• Brand Name: POWERTEK II PLUS SHAVER HANDPIECE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6999221
• MDR Text Key: 192793324
• Report Number: 0001825034-2017-09692
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 906063
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 11/03/2017 Patient Sequence Number: 1