MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X12MM LOW PRO CORT SCR STE; SCREW, FIXATION

Catalog Number 851235012

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Information (3190)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).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 report will be submitted.Product not returned.

Event Description

It was reported that the product was received with debris in the sterile packaging.No patients were involved.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h1, h2, h3, h6, h10.Visual inspection of the returned product found a hair-like debris inside the sterile barrier.The debris was sent out for ftir spectrum analysis.However, the debris could not be conclusively identified.Device history record was reviewed and no discrepancies were found.This product was 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.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: 3.5X12MM LOW PRO CORT SCR STE
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10108438
• MDR Text Key: 194365958
• Report Number: 0001825034-2020-02201
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 851235012
• Device Lot Number: 547070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1