MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, LONG, 8.5X220MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: catalog#: 47-2486-122-40; lot#: 3068948; name: cortical bone screw, 4x22mm.Catalog#: 47-2486-122-40; lot#: 3076753; name: cortical bone screw, 4x22mm.Catalog#: 47-2486-128-40; lot#: 3064872; name: cortical bone screw, 4x28mm.Catalog#: 47-2488-000-04; lot#: 3054260; name: washer small.Catalog#: 47-2488-010-05; lot#: 3054424; name: proximal humerus nail cap, 10.5x5mm.Catalog#: 47-2486-038-40; lot#: 3054464; name: blunt tip screw, 4x38mm.Catalog#: 47-2486-042-40; lot#: 3054515; name: blunt tip screw, 4x42mm.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device 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).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00070.
Event or Problem Description
It was reported that after 7 weeks from the initial, surgeon found #2 screw of the proximal screws was backed out from the proper position.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that the patient underwent primary operation with ann nail on (b)(6), 2021.After 7 weeks, the surgeon found the second most proximal screw backed out from the proper position.The surgeon is keeping an eye on the patient condition and no revision has been planned so far.The corelock mechanism was utilized.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.No medical data relevant to the case has been received.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Surgical technique sap: explains that the locking of the corelock is done using the corelock driver with torque limiting handle.Turn slowly clockwise to tighten and engage the corelock mechanism until a click is felt from the torque limiting handle.Conclusion: it was reported that the patient underwent primary operation with ann nail on (b)(6), 2021.After 7 weeks, the surgeon found the second most proximal screw backed out from the proper position.The surgeon is keeping an eye on the patient condition and no revision has been planned so far.The corelock mechanism was utilized.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).Neither x-rays, operative notes, office visit notes, nor devices or photos of the devices were received; therefore the condition of the components is unknown.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.Based on the investigation it could be assumed that possible contributing factors to the migration of the screw might be multifactorial related to either patient condition and behavior, implantation procedure or design features.If and to what extent any of these aspects may have influenced the backing out of the screw remains unknown.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.Further investigation has been initiated in order to determine the need of potential corrective and / or preventive actions.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 change to previously reported event.

• Brand Name: PROXIMAL HUMERUS, RIGHT, LONG, 8.5X220MM
• Common Device Name: AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL
• 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: 13505220
• Report Number: 0009613350-2022-00069
• Device Sequence Number: 19831348
• Product Code: HSB
• UDI-Device Identifier: 00889024505902
• UDI-Public: 00889024505902
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 02/24/2022

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 Model Number: N/A
• Device Catalogue Number: 47-2496-220-08
• Device Lot Number: 3008137
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2020
• 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
• Patient Sex: Unknown