MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENTLE THREADS INTERFERENCE SCREW 7X20MM ROUND HEAD; SCREW, FIXATION

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The commingled product that was inside of the package was part#: (b)(4), lot#: 625450, manufacture date: october 19, 2017, sterile expiry date: (b)(6) 2022.Udi # : (b)(4).(b)(4).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.

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Event Description

No further event information available at the time of this report.

• Brand Name: GENTLE THREADS INTERFERENCE SCREW 7X20MM ROUND HEAD
• 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: 7800885
• MDR Text Key: 117720759
• Report Number: 0001825034-2018-08296
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK041274
• 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,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2022
• Device Model Number: N/A
• Device Catalogue Number: 905612
• Device Lot Number: 611330
• 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: 10/10/2017
• Is the Device Single Use?: Yes
• 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