MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130°, LEFT, 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	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: znn, cmn lag screw, 10.5 mm, 120 mm including set screw, ref: 47248512010, lot: 2945645.X-rays were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.An e-mail requesting the following additional information was sent on january 22, 2019 to the appropriate representatives.The availability of the affected product(s) (non-availability with a rationale); surgical reports; all available intraoperative pictures; patient dob, weight, height, bmi and all relevant history; were there any contributing conditions related to the event (ex: trauma, illness, previous surgery, related non-compliance, patient anatomy)? 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 patient underwent revision surgery due to nail fracture.
Additional Manufacturer Narrative
Investigation results were made available.Dhr review: ref:(b)(4).Lot:2936288 yield:30.Delivered:30.No ncr were foun raw material certificate reviewed on: (b)(6) 2019 the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Ref:(b)(4); lot:2945645 - yield:60 - delivered:58 - scrapped:02 - reason for scrapping: welds on the surface.Following ncr were found: - 2 parts scrapped due to (ncr #500060517) the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: medical : revision due to implant fracture event description: it was reported that the patient was implanted with zimmer products on (b)(6) 2018 and underwent revision surgery on (b)(6) 2018 due to nail fracture.Review of received data - the review of the received x-rays was done by health care professional: - left hip with femur ap-view (undated): situation after probably a simple transverse subtrochanteric femur fracture according to ao classification a2.1 with subsequent implantation of a femoral nail.The fracture gap is clearly visible, the edges of the fracture is not noticeably sclerosed.No evidence of failure of the implant components.Left hip lateral (undated): suboptimal image quality.No meaningful assessment can be done.Left hip with femur ap-view (undated): visible breakage of the nail in the area of the entry point of the lag screw with deviation of the proximal part of the nail (approximately 10 degrees).Medially, the femur fracture appears consolidated (green arrow), laterally visible gap in the area of the former fracture (marked in green) with sclerosis at the edge of the fracture (red arrow).Compared ap-view: the position of the lag screw and the distal part of the nail has not changed noticeably.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 and showed that the product combination was approved by zimmer biomet.-applicable instruction for use (ifu) : fatigue fracture of implant is listed in the ifu under the section "adverse effects".Conclusion summary: it was reported that the patient was implanted with zimmer products on (b)(6) 2018 and underwent revision surgery on (b)(6) 2018 due to nail fracture.The znn nail was in vivo for approx.3 months.No product was returned to zimmer biomet for in-depth analysis.The received x-rays confirm the breakage of the znn nail.There are several factors which may have contributed to the nail breakage.It can be the nail was overstressed during the in vivo time or a wrong patient behavior can also be the cause for the breakage.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information and performed investigation, an exact root cause for the plate breakage 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).
Event or Problem Description
Investigation results are now available.

• Brand Name: CMN FEMORAL NAIL, CCD 130°, LEFT, 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: 8266735
• Report Number: 0009613350-2019-00030
• Device Sequence Number: 11256099
• Product Code: HSB
• UDI-Device Identifier: 00889024299894
• UDI-Public: 00889024299894
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/25/2019

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 Model Number: N/A
• Device Catalogue Number: 47-2493-383-11
• Device Lot Number: 2936288
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/01/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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