MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 125°, RIGHT, ø 11.5 MM, 38 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: item# 47-2484-042-50, lot# 63545426, z nail 5.0x42.5 cort screw fa.Item# 47-2484-045-50, lot# 63567688, z nail 5.0x45 cort screw fa.Item# 47-2485-085-10, lot# 2763050, znn, cmn lag screw, 10.5 mm, 85 mm, including set screw.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 manufacturer did not receive x-rays for review.Revision surgery details were received and will be reviewed as part of ongoing investigation.Device history record (dhr) was reviewed and no discrepancies were found.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 patient had a revision surgery approximately four months post implantation due to non-union.As a result, nail was removed and replaced with another nail.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend considering the following event is identified: nail breakage.Event summary: it was reported that a patient underwent procedure on (b)(6), 2018.Subsequently, the patient was revised due to non union on (b)(6), 2018.It was reported that the znn cm nail broken through the lag screw.Nail was removed and replaced with another cm nail.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation all involved devices are intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Conclusion summary it was reported that a patient underwent procedure on (b)(6) 2018.Subsequently, the patient was revised due to non union on (b)(6), 2018.It was reported that the znn cm nail broken through the lag screw.Nail was removed and replaced with another cm nail.The nail was in vivo for approx.4 months.The device has not been returned for product analysis.Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implants were received; therefore the condition of the components is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Based on the given information and the results of the investigation, the breakage of the znn nail could not be confirmed as the alleged failure could not be identified or reproduced.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).
Event or Problem Description
No change to previously reported event.

• Brand Name: CMN FEMORAL NAIL, CCD 125°, RIGHT, ø 11.5 MM, 38 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: 8304842
• Report Number: 0009613350-2019-00042
• Device Sequence Number: 154154
• Product Code: HSB
• UDI-Device Identifier: 00889024299801
• UDI-Public: 00889024299801
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-380-11
• Device Lot Number: 2823807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 05/31/2019
• 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: Hospitalization; Required Intervention