MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130, LEFT, 10 MM, 21.5 CM

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: z nail cpm neu nail cap 0mm, catalog no#: 47-2487-002-00; lot#: 63971653, therapy date: (b)(6) 2019.The manufacturer did not receive x-ray for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, 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
During surgery the surgeon faced difficulty while removing the implant and hence increasing the operating time.
Event or Problem Description
During the surgery, the surgeon faced difficulty while removing the implant and hence increasing the operating time.
Additional Manufacturer Narrative
Additional information which was received on (b)(6) 2019.Medical product: z nail cpm neu nail cap 0mm; item#47248700200; lot#63971653.Cm extrct adapt cann m11 thrd; item#00249009011; lot#unknown.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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: additional: h2 ; correction: b4 - g4 - g7 - h10.Based on additional information received on 28- nov-2019 we realized that we are not the legal manufacturer of the device.The legal manufacturer is zimmer biomet warsaw.In the meantime this event has been captured under warsaw (b)(4) and has been linked to winterthur (b)(4).As this event is captured under warsaw (b)(4), this complaint will be set to not a complaint.So please void it from your database.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Based on additional information received on 28- nov-2019 we realized that we are not the legal manufacturer of the device.The legal manufacturer is zimmer biomet warsaw.In the meantime this event has been captured under warsaw (b)(4) and has been linked to winterthur (b)(4).As this event is captured under warsaw (b)(4), this complaint will be set to not a complaint.So please void it from your database.

• Brand Name: CMN FEMORAL NAIL, CCD 130, LEFT, 10 MM, 21.5 CM
• Common Device Name: CMN FEMORAL NAIL, CCD 130, LEFT, 10 MM, 21.5 CM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9382072
• Report Number: 0009613350-2019-00694
• Device Sequence Number: 13573079
• Product Code: HSB
• UDI-Device Identifier: 00889024298958
• UDI-Public: 00889024298958
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-213-10
• Device Lot Number: 2876575
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/13/2019; 01/28/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/11/2019; 02/10/2020
• 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: Other
• Patient Age: 44 YR
• Patient Weight: 92