MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCK SCREW SQ 2.7MM 16MM STE; PROSTHESIS TRAUMA

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 001825034-2021-03023, 0001825034-2021-03024, 0001825034-2021-03025, 0001825034-2021-03026, 0001825034-2021-03027, 0001825034-2021-03028.

Event Description

It was reported upon inspection that there was debris in the sterile package.

Manufacturer Narrative

(b)(4).Reported event was not confirmed as visual examination of the returned product found no evidence of debris.As the products were determined to be acceptable as no debris was found as reported, a limited investigation process was followed.No product failure was found as the products are within specifications.No further investigation or action is required after review.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: LOCK SCREW SQ 2.7MM 16MM STE
• Type of Device: PROSTHESIS TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12738790
• MDR Text Key: 279611496
• Report Number: 0001825034-2021-03026
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00887868450280
• UDI-Public: (01)00887868450280(17)310223(10)974000
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• 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: 131827116
• Device Lot Number: 974000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1