MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 125, RIGHT, 10 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-rays for review.Other documents were received and will be reviewed as part of ongoing investigation.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 an unknown side and underwent a revision surgery due to implant fracture.
Additional Manufacturer Narrative
Investigation results were made available.1.Event description: it was reported that the patient was implanted on (b)(6) 2020 and subsequently patient experienced implant fracture.Patient underwent revision on (b)(6) 2021 with the device being explanted.Harm: s3 - instability, moderate.Hazardous situation: implant deteriorates, breaks or loses function post-operatively.2.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.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.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.5.Conclusion: it was reported that the patient was implanted on dec 21, 2020 and subsequently patient experienced implant fracture.Patient underwent revision on jun 23, 2021 with the device being explanted.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 non-conformance 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, RIGHT, 10 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: 12275242
• Report Number: 0009613350-2021-00370
• Device Sequence Number: 14335594
• Product Code: HSB
• UDI-Device Identifier: 00889024298835
• UDI-Public: 00889024298835
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-210-10
• Device Lot Number: 3038230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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