MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENTLE THREAD 10X30MM FULL THR; SCREW, FIXATION

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Products were returned and reviewed.The label on the outer package does not match the label on the inner package; therefore, the complaint is confirmed and the product was comingled.Review of device history records found these units were released to distribution with no deviations or anomalies.Root cause is related to production & process control.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.(b)(4).Additional concomitant medical products: 905612, gentle thread 7x20mm round hd, lot 611330.(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08296.

Event Description

It was reported that during surgery, it was noticed that a wrong product was found inside the package.The inner blister product identification labeling did not match what the outer carton device labeling stated.No impact to the patient or surgery was reported.

• Brand Name: GENTLE THREAD 10X30MM FULL THR
• Type of Device: SCREW, FIXATION
• 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: 8025229
• MDR Text Key: 125760707
• Report Number: 0001825034-2018-10107
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K041274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 905629
• Device Lot Number: 625450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-3176-2018
• Patient Sequence Number: 1