MAUDE Adverse Event Report: ZIMMER GMBH NCB, DF TARGETING INSTRUMENT FOR RIGHT PLATES; N/A

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
Event or Problem Description
It was reported that the ncb targeting instrument's end snapped off.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.This complaint (b)(4) is a duplicate of the complaint (b)(4) submitted under the reference 0009613350-2019-00073.This complaint will be set to not a complaint in oir database.Please delete this report from your database.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
This complaint (b)(4) is a duplicate of the complaint (b)(4) submitted under the reference 0009613350-2019-00073.This complaint will be set to not a complaint in oir database.Please delete this report from your database.

• Brand Name: NCB, DF TARGETING INSTRUMENT FOR RIGHT PLATES
• Common Device Name: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8330342
• Report Number: 0009613350-2019-00056
• Device Sequence Number: 62309
• Product Code: FZX
• UDI-Device Identifier: 00889024289444
• UDI-Public: 00889024289444
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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: 02.00024.070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 07/04/2019
• 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