MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH BLUNT TIP SCREW, 4X50MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	47-2486-050-40
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item#: 47-2496-260-08; lot#:3054421 ;item name: proximal humerus, right, long, 8.5x260mm.Report source-foreign- belgium.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 report: 0009613350 - 2022 - 00558.
Event or Problem Description
It was reported that the patient underwent revision surgery due to migration of the screw.
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 three blunt tip screws were returned for investigation.The other products involved in the reported event were not returned, namely the nail, the nail cap, the cortical bone screw and the humerus ball nose guidewire.The three blunt tip screws were visually inspected and on all of them it is possible to see that the threaded parts are flattened.However, no significant difference can be found between the migrated screw (blunt tip screw, 4x50mm) and the non-migrated screws (blunt tip screw, 4x46mm).The heads of the blunt tip screws appear inconspicuous.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Two undated radiographs showing frontal views of the proximal right humerus were received and assessed by a radiologist.The right image displays an acute mildly displaced spiral fracture of the proximal humerus diaphysis; therefore, it is assumed that this is the first acquired postoperative image after the implantation.Here, the three threaded screws appear appropriately positioned.The left image displays the healed proximal humerus diaphysis; therefore, it is assumed that this image was acquired at a later time point from the image on the right.On this image the most inferior screw appears backed out and demonstrates spacing between the screw head and the lateral cortex of the humerus.Bone quality is normal, without periprosthetic radiolucency.Based on the investigation, the event can be confirmed.It can be assumed that there are multiple factors contributing to the migration of the screws, 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BLUNT TIP SCREW, 4X50MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 15665247
• Report Number: 0009613350-2022-00559
• Device Sequence Number: 17927618
• Product Code: HSB
• UDI-Device Identifier: 00889024505490
• UDI-Public: (01)00889024505490(17)260228(10)3068966
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/20/2023

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: 02/28/2026
• Device Model Number: 47-2486-050-40
• Device Catalogue Number: 47-2486-050-40
• Device Lot Number: 3068966
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• 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