MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X16MM LOW PRO CORT SCR STE; TRAUMA IMPLANT

Catalog Number 851235016

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(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 mdr will be submitted.

Event Description

It was reported that upon inspection at the warehouse, it was found that there was debris in the sterile package.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4) updated: b4, b5, d10, g4, h1, h2, h3, h6, and h10 reported event was considered confirmed via visual evaluation of the returned product identified that there is debris inside the sterile package.Ats also conducted a ftir analysis which stated the ftir spectrum of the very small hair-like debris sample matches the major peaks in the ftir spectrum of a polyamide like sylvamid.Device history record was reviewed and no discrepancies relevant to the reported event were found.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: 3.5X16MM LOW PRO CORT SCR STE
• Type of Device: TRAUMA IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9956987
• MDR Text Key: 187873559
• Report Number: 0001825034-2020-01582
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 851235016
• Device Lot Number: 432740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1