MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FIB ANATOMIC LOCK RT 4H STE; TRAUMA IMPLANTS

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

Cmp-(b)(4).Report source: (b)(6).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.Will be returned.

Event Description

It was reported that the product had a hair-like substance was found on the sterile package.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

Cmp-(b)(4).Updated: b4, b5, d4 (exp date, udi), d9, e1 (zip, phone), g3, h1, h2, h3, h4, h6, h10 reported event was confirmed as visual evaluation of the returned product found a hair-like debris, foreign debris, and staining on the outer sterile pouch.The debris and staining are not within the sterile barrier and therefore, the sterile barrier has not been breached.Device history record was reviewed and no discrepancies relevant to the reported event were found.The condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.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: FIB ANATOMIC LOCK RT 4H STE
• Type of Device: TRAUMA IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15391593
• MDR Text Key: 299708272
• Report Number: 0001825034-2022-02082
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00887868445996
• UDI-Public: (01)00887868445996(17)320805(10)958080
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111663
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• 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: 856207004
• Device Lot Number: 958080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2022
• 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