MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, Ã 11X160MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: therapy date: (b)(6) 2022.Cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3054458.Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3054381.Cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3064872.Blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3039762.Proximal humerus, right, 11x160mm; catalog#: 47-2496-160-11; lot#: 3059662.Torque limiting handle; catalog#: 27923; lot#: unknown.Event description: operation was performed with ann nail on (b)(6) 2021.After 7 weeks from the initial, surgeon found the #3 proximal screw was backed out from the proper position.Therefore, revision surgery was conducted on feb 9, and only migrated screw was explanted.Review of received data: no medical records available.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.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.Surgical technique: 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.Dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.A complaint history was run which identified additional complaints for the reported product and lot number.Conclusion: operation was performed with ann nail on (b)(6) 2021.After 7 weeks from the initial, surgeon found the #3 proximal screw was backed out from the proper position.Therefore, revision surgery was conducted on feb 9, and only migrated screw was explanted.The quality records show that all specified characteristics have met the specifications valid at the time of production.Based on the investigation it could be assumed that further possible contributing factors to the migration of the screw might be multifactorial related to either patient condition, behavior or implantation procedure.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.A deeper investigation was performed (refer to (b)(4)) which identified the design limitation of the corelock mechanism as a potential contributing factor as well.However, further biomechanical testing was carried out and as the product performance is in an acceptable range in comparison with legally marketed similar devices, no design changes were conducted.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.The need for corrective measures is not indicated and zimmer (b)(4) manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that a operation was performed with ann nail system.After 7 weeks from the initial, surgeon found one of the proximal screw was backed out from the proper position.Therefore, revision surgery was conducted and only migrated screw was explanted.

• Brand Name: PROXIMAL HUMERUS, RIGHT, Ã 11X160MM
• Type of Device: AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 14710760
• MDR Text Key: 294663550
• Report Number: 0009613350-2022-00344
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2496-160-11
• Device Lot Number: 3059662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male