MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 125, LEFT, 10 MM, 21.5 CM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-rays 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
Patient was implanted on the left side and underwent revision surgery due to implant fracture and iterative fracture of the proximal femur.
Additional Manufacturer Narrative
Investigation results were made available.Event description: product was implanted on unknown dated and revised on (b)(6) 2019 due to nail fracture and iterative fracture of the proximal femur.Plate osteosynthesis of the femur was performed.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.No additional information has been received despite multiple follow-up requests.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.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.There was a documentation correction due to wrong document revision referenced (ncr#: 500068567).No ncr with a potential correlation to the reported event was found.Conclusion: product was implanted on unknown dated and revised on (b)(6) 2019 due to nail fracture and iterative fracture of the proximal femur.Plate osteosynthesis of the femur was performed.Based on the investigation the reported event cannot be confirmed.Neither x-rays, operative notes, office visit notes, nor device(s) or photos of the device(s) were received; therefore the condition of the component is unknown.It remains unknown how long the nail was implanted and whether a bone fusion has occurred.Moreover, it cannot be determined whether the iterative fracture of the proximal femur has occurred prior or after fracture of the nail.Patient factors that may have affected 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.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing 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 125, LEFT, 10 MM, 21.5 CM
• Common Device Name: CMN FEMORAL NAIL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9534944
• Report Number: 0009613350-2019-00821
• Device Sequence Number: 19421479
• Product Code: HSB
• UDI-Device Identifier: 00889024298873
• UDI-Public: 00889024298873
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-211-10
• Device Lot Number: 2972844
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 10/28/2020
• 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: Hospitalization; Required Intervention