MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RNGLC+ QK CONNECT ACET FLX DRL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Reported event was confirmed with product return.Visual inspection confirmed the presence of worms and debris inside the sealed pouch.Multiple worms were observed stuck under the adhesive flap which seals the pouch.Additional insect debris was observed inside the pouch.Review of the device history records identified no related deviations or anomalies during manufacturing.These products were likely non-conforming when they left zimmer biomet control.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.No actions needed at this time.This complaint was determined not to be a new confirmed quality or manufacturing issue.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.

Event Description

It was reported by the distributorship that the incoming inspection team member found a lot of bugs in the package.No patient involvement.No further event information available at the time of this report.

• Brand Name: RNGLC+ QK CONNECT ACET FLX DRL
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 10495033
• MDR Text Key: 205712593
• Report Number: 0001825034-2020-03399
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• 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: 31-424204
• Device Lot Number: 137772B1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1