MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130°, RIGHT, 11.5 MM, 40 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department.Concomitant medical products: item: set screw, 8 mm, 21 mm, catalog #: 47249300000, lot #: 12772309; item: znn, cmn lag screw, catalog #: 47248510510, lot #: 2855436.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The device history records were reviewed and found to be conforming.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 the patient had an intramedullary nailing for a right sub-trochanteric femoral fracture.Subsequently, on her first day post-op, she did develop some supraventricular tachycardia that improved with metoprolol and iv fluids boluses.The patient was asymptomatic during these episodes and resolved after just one day.During that day she had these episodes a few times.She was monitored on telemetry without further events and was discharged to the rehab facility.
Event or Problem Description
Please disregard the report and void it from your system because this complaint is not device related as per communication received from healt care provider.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional and corrected information are filled in the following fields: please disregard the report and void it from your system because this complaint is not device related as per communication received from healt care provider.Zimmer gmbh considers this case as not a complaint.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: CMN FEMORAL NAIL, CCD 130°, RIGHT, 11.5 MM, 40 CM
• Common Device Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8554809
• Report Number: 0009613350-2019-00269
• Device Sequence Number: 2308431
• Product Code: HSB
• UDI-Device Identifier: 00889024300040
• UDI-Public: 00889024300040
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-402-11
• Device Lot Number: 2512621
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/06/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 114