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 Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: cmn femoral nail, ccd 125°, left, 11.5 mm, 36 cm; catalog#: 47-2493-361-11 ; lot#: 2921753.Znn, cmn lag screw, 10.5 mm, 90 mm, including set screw; catalog#: 47-2485-090-10; lot#: 3025991.X-rays, photographs, were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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).The following reports are associated with this event: 0009613350-2022-00120.In transit to manufacturer.
Event or Problem Description
It was reported that: after 2 months of implantation there was a break in the fitting of the proximal fixation screw of the femoral neck together with the femoral nail, which resulted a revision.
Event or Problem Description
No event update.Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Additional: d9, h2, h6.Correction: b4, b5, g3, g6, h3, h10.Product evaluation: visual examination: the znn nail and lag screw were returned for investigation.The visual examination shows that the tabs of the lag screw were fractured.The broken two pieces have not been returned.Additionally, there are damages and deformations visible on the lag screw shaft.It can be assumed that the damages and deformations were occurred while trying to remove the lag screw.The nail shows similar damages and deformations in the hole for the lag screw.The nail is not fractured.Review of the device history records identified no deviations or anomalies during manufacturing.No further "due diligence" required as all required information to support the conclusion is available or was already requested.Devices are used for treatment.The product combination was approved by zimmer biomet.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.Review of x-rays: two x-ray pictures were received.One of them shows a fractured femur and the other is a post-operative x-ray shows the fractured lag screw.The fractured pieces can be seen o the post-op x-ray.No surgical report available for investigation.The investigation did not identify a nonconformance or a complaint out of box (coob).The returned products were visually inspected.The lag screw tabs were broken off.Both returned devices were highly damaged.It is not known when and how the lag screw was fractured.However, a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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).

• 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: 13658386
• Report Number: 0009613350-2022-00117
• Device Sequence Number: 5110994
• Product Code: HSB
• UDI-Device Identifier: 00889024298439
• UDI-Public: 00889024298439
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/01/2022

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-090-10
• Device Lot Number: 3025991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/01/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 106 KG