MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X58MM; ROD, FIXATION, INTRAMEDULLARY

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: proximal humerus, right, 11x160mm, lot#: 3068953, item#: 47249616011.Blunt tip screw, 4x36mm, lot#: 3064860, item#: 47248603640.Blunt tip screw, 4x38mm, lot#: 3082026, item#: 47248603840.Cortical bone screw, 4x28mm, lot#: 3091274, item#: 47248612840.Cortical bone screw, 4x28mm lot#: 3091558, item#: 47248612840.Proximal humerus nail cap, 0mm, lot#: 3091320, item#: 47248801000.Report source ¿ foreign ¿ japan.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2022 - 00503, 0009613350 -2022 - 00504, 0009613350 -2022 -00505.
Event or Problem Description
It was reported that the patient underwent revision surgery due to screw migration, approximately 2 weeks post operation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The 36mm and the two 38mm blunt tip screws look mainly inconspicuous, with minimal flattened threads.The 58mm blunt tip screw (ascending screw) however shows lots of flattened threads, almost throughout the whole length of the screw.The returned nail is mainly inconspicuous throughout the outer surface area.The corelock mechanism for the ascending screw is worn, as per signs of wear apparent on the screw itself, and the corresponding bore hole exit of the nail has some scratches, likely due to contact with the screw.The corelock mechanism for the remaining screws is mainly inconspicuous.However, there are occasional scratches at the bore hole exit.The nail cap and both cortical screws are inconspicuous.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.The 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." five undated radiographs and two undated ct images of the proximal right humerus were received and assessed by a radiologist (hcp) with the following assessment: "proximal right humeral intramedullary nail and screw fixation has been performed in the setting of a proximal humeral fracture.Three of the surgical screws are malpositioned with the screw heads displaced from the humeral cortical surface.There is no hardware fracture and humeral alignment is maintained.The distal screws are normally positioned.Bone quality is osteopenic." based on the investigation, it could can be assumed that possible contributing factors contributing to the migration of the screws might could 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.An additional deeper investigation was performed which identified the design limitation of the corelock mechanism of the affixus nail as a potential contributing factor.As part of the deeper investigation, a scientific literature search was conducted and a systematic review of the outcome of intramedullary nailing for acute proximal humerus fracture showed that screw migration and perforation into the joint is the second most common complication following secondary loss of reduction.In addition, scientific literature of competitor and predicate devices were assessed.This review has shown that the affixus natural nail proximal humeral system performs better and/or in equal range in comparison with legally marketed similar devices.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BLUNT TIP SCREW, 4X58MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• 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: 15508123
• Report Number: 0009613350-2022-00506
• Device Sequence Number: 5856207
• Product Code: HSB
• UDI-Device Identifier: 00889024505537
• UDI-Public: (01)00889024505537(17)251130(10)3054254
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-058-40
• Device Lot Number: 3054254
• 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: 09/15/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose