MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FIB ANATOMIC LOCK LEFT 8H STE; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign, event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
Event or Problem Description
It was reported debris was identified in the sterile package.No further information is available at the time of this reporting.
Additional Manufacturer Narrative
It was determined this device did not cause or contribute to a serious injury and has not been identified as a reportable malfunction.Please void this submission.
Event or Problem Description
It was determined this device did not cause or contribute to a serious injury and has not been identified as a reportable malfunction.Please void this submission.

• Brand Name: FIB ANATOMIC LOCK LEFT 8H STE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9152045
• Report Number: 0001825034-2019-04400
• Device Sequence Number: 2607384
• Product Code: HRS
• UDI-Device Identifier: 00887868061974
• UDI-Public: 00887868061974
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 856206008
• Device Lot Number: 408530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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