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

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

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.(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 a surgery, the surgical team noticed that the reference labeling on the inner package is different than the reference on the external package.The inner package was left unopened.No patient harm was reported.No further information is available at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Review of device history records found these units were released to distribution with no deviations or anomalies.Investigation of the issue determined the root cause is related to production & process control.Corrective and preventive actions have been initiated for the reported 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.

• Brand Name: GENTLE THREAD 7X20MM ROUND HEAD INTERFERENCE SCREW
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7744928
• MDR Text Key: 115898502
• Report Number: 0001825034-2018-05736
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: PK041274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/08/2018
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-3176-2018
• Patient Sequence Number: 1