MAUDE Adverse Event Report: DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DISTENSION UNIT, FLUID, ARTHROSCOPIC

Model Number 284580

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Investigation summary: the device was received and evaluated at the service center. There was no allegation of malfunction against the device from the customer, however, defects were found with the device during service evaluation. It was found that the covers were damaged and one tension rocker arm was sticking. The insertion lever was defective and the unit was not calibrated correctly. The defective insertion lever along with the irreparable cover was replaced and the device was cleaned, newly calibrated, tested and found to be working according to specifications. User mishandling is one possible root cause of the damage to the covers and would have possibly caused the damage to the other defective components. The service history has been reviewed in lieu of the device history record for this device since it was previously serviced. The device was last serviced on (b)(6) 2017 and passed all functional testing before being returned to the customer. At this point in time, no corrective action is required, and no further action is warranted. Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

Event Description

It was reported from (b)(6) that during service and repair, it was determined that the 4580 fms duo+ pump/shaver combo -ns device had a defective insertion lever. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 4580 FMS DUO+ PUMP/SHAVER COMBO -NS
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 10507189
• MDR Text Key: 208018797
• Report Number: 1221934-2020-02418
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 284580
• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial