MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products item# 47248510510, lot# 3026107, znn, cmn lag screw, 10.5 mm, 105 mm including set screw.Item# 47248403550, lot# 64850532, 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.Event description: it was reported that the patient was implanted on an unknown date and underwent a revision surgery on (b)(6) 2021 due to implant fracture.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: x-ray was reviewed by a radiologist.There is a comminuted femoral neck fracture with femoral nail and screw fixation.The femoral nail is fractured at the screw level with varus angulation at the nail fracture site.The screw is intact.The distal aspect of the nail is not included on the image.Images: review of the received images shows that the nail was broken through the hole for the lag screw.Based on the images the nature of the fracture cannot be evaluated.Surgical report: there is an implant surgery sheet and an explant surgery sheet available with some information like product ref and lot numbers.No other relevant information is available.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Conclusion: it was reported that the patient was implanted on an unknown date and underwent a revision surgery on (b)(6) 2021 due to implant fracture.The quality records show that all specified characteristics (material, dimensions, surface, etc.) for the znn nail have met the specifications valid at the time of production.No product was returned; therefore, visual and dimensional evaluation could not be performed.The implant date of the znn nailing system is unknown.Therefore, it cannot be said how long the nail was in vivo.The removal was on (b)(6) 2021.Review of the received images shows that the nail was broken through the hole for the lag screw.Review of the received images shows that the nail was broken through the hole for the lag screw.However, based on the images the nature of the fracture cannot be evaluated.It is possible that the nail was fractured due to fatigue which can occur due to a cyclic overloading.Possible contributing factors to the overload could be a not properly healed bone fracture and / or not adherence to the postoperative protocol (patient behavior).However, based on the available information and performed investigation, an exact root cause for the nail breakage could not be determined.The investigation results did not identify a non-conformance or a complaint out of box (coob).
Event or Problem Description
It was reported that patient underwent revision surgery due to implant fracture.

• Brand Name: CMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 21.5 CM
• Common Device Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 12237117
• Report Number: 0009613350-2021-00352
• Device Sequence Number: 17047079
• Product Code: HSB
• UDI-Device Identifier: 00889024298927
• UDI-Public: 00889024298927
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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 Model Number: N/A
• Device Catalogue Number: 47-2493-212-11
• Device Lot Number: 2973566
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/28/2021
• 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