MAUDE Adverse Event Report: ZIMMER GMBH NCB-DF TARGET DEVICE FOR RIGHT PLATES; N/A

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.Notes: 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.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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
It was reported that the surgeon tried to assemble the guide during the surgery and the end snapped off.
Event or Problem Description
Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.As for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefore tried several times to receive additional information for this case.Currently, additional information is not available.Trend analysis: no trend considering the following event is identified: functional : fracture : device fracture dhr-review: ref#: 02.00024.070, lot#: 8367258, yield: 30, delivered: 30.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event description: it is reported that the end of the targeting device snapped of during assembling.Review of received data: no other case-relevant documents received.Devices analysis: visual examination: the targeting device was returned for an investigation.One of the retainer jaws has fractured off.The fractured off part has not been returned.There are some more signs of usage visible.No other conspicuousness found.Review of product documentation: inspection plan surgical technique: in the surgical technique it is described that the plate should be attached with both connection bolts on the targeting device, to ensure a secure connection and to avoid an overstrain of the retainer jaws.Conclusion summary: the targeting device was returned for an investigation and it can be confirmed that one of the retainer jaws has fractured off.In the surgical technique it is described that the plate should be attached with both connection bolts on the targeting device, to ensure a secure connection and to avoid an overstrain of the retainer jaws.Like this the applied force is transferred only via the connection bolts, but not via the connection to the plate.It might be possible that excessively high bending forces have been applied to the instrument, leading to the fracture of the retainer jaw.However, based on the available information an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: NCB-DF TARGET DEVICE 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: 8342413
• Report Number: 0009613350-2019-00073
• Device Sequence Number: 2127332
• 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): 08/14/2019

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: 08367258
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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