MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X26MM LOW PRO CORT SCR STE; SCREW, FIXATION

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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 there was debris in the sterile package.No patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product identified that there is a small hair-like debris inside the sterile package.The complaint has been confirmed by visual evaluation.Ftir analysis could not be conducted as the foreign material in the package was too small and could not be located by the lab for testing.Review of the device history records identified no related deviations or anomalies during manufacturing.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 is available at the time of this report.

• Brand Name: 3.5X26MM 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: 9749704
• MDR Text Key: 200694248
• Report Number: 0001825034-2020-00696
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00887968066140
• UDI-Public: (01)00887968066140
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 851235026
• Device Lot Number: 179640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1