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

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: FIB ANATOMIC LOCK RT 4H STE
• Common Device Name: 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
• Report Number: 0001825034-2022-02082
• Device Sequence Number: 4905414
• Product Code: HRS
• UDI-Device Identifier: 00887868445996
• UDI-Public: (01)00887868445996(17)320805(10)958080
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown