MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW, 10.5 MM, 90 MM, INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: cmn femoral nail, ccd 130, right, 11.5 mm, 34 cm; catalog#: 47-2493-342-11; lot#: 2963206 therapy date: jan 1, 2021.The manufacturer received other source documents 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 right side and underwent a revision surgery due to implant fracture.During the surgery, since the femoral neck screw and both lips were fractured, the devices could not be explanted.The surgery was delayed by 60 minutes.
Additional Manufacturer Narrative
Review of event description: it was reported that the patient received an implant on (b)(6) 2019 and revised on (b)(6) 2021 due to implant fracture.During the surgery, since the femoral neck screw and both lips got fractured, the devices could not be explanted.The surgery was delayed by 60 mins.Review of received data: - no medical data relevant to the case has been received.Product evaluation: - visual examination: visual examination of the returned device identified 2 fractured pieces of the device were returned.Not all pieces of the devices were returned.The two pieces are from the end of the lag screw and each fractured from the non-returned piece of the device.The surfaces have scratches and gouges.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the product combination was approved by zimmer biomet.- dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production.- ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient received an implant on (b)(6) 2019 and revised on (b)(6) 2021 due to implant fracture.During the surgery, since the femoral neck screw and both lips got fractured, the devices could not be explanted.The surgery was delayed by 60 mins.Based on the investigation the reported event can be confirmed that the device fractured; however it cannot be confirmed if the fractured components occurred in vivo or during device removal attempts.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
No event update.Investigation results are now available.

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 90 MM, INCLUDING SET SCREW
• 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
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12157909
• Report Number: 0009613350-2021-00341
• Device Sequence Number: 17086015
• Product Code: HSB
• UDI-Device Identifier: 00889024298439
• UDI-Public: 00889024298439
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/09/2021

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 Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-090-10
• Device Lot Number: 2968566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 73 KG