MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X24MM LOW PRO CORT SCR STE; PLATE, FIXATION

Model Number N/A

Device Problems Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

(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 upon inspection of the product in the warehouse, there was debris in the sterile packaging.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the inner pouch confirms there was a piece on unknown debris found within the sealed pouch.A tappi chart was used to measure the size of debris and was found to be non-conforming.The reported event is confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Ftir spectrum analysis of the debris concluded that it is made of polypropylene.The work instruction provides adequate detail instructing the operator to look for any contamination.The likely condition of the product when it left zimmer biomet was non-conforming.The root cause of the reported event is the operator not following instructions during the manufacturing process.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: 3.5X24MM LOW PRO CORT SCR STE
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7664018
• MDR Text Key: 113246746
• Report Number: 0001825034-2018-04357
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK111663
• 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: 02/22/2019

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 851235024
• Device Lot Number: 221730
• Other Device ID Number: (01) 00887868055133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1