MAUDE Adverse Event Report: ZIMMER MANUFACTURING SWITZERLAND GMBH PROXIMAL HUMERUS, LEFT, 9X160MM; TRAUMA PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision due to screw migration 3-months post-implantation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices; blunt tip screw, 4x48mm item# 47-2486-048-40 lot# 3048866, blunt tip screw, 4x48mm item# 47-2486-048-40 lot# 3073797, blunt tip screw, 4x50mm item# 47-2486-050-40 lot# 3010668, blunt tip screw, 4x50mm item# 47-2486-050-40 lot# 3024741, torque limiting handle item# 27923 lot# n/a, ann cort bone screw 4 x 30mm , item# 47-2486-130-40 , lot# 3024383, ann cort bone screw 4 x 30mm , item# 47-2486-130-40 , lot# 3081983, ann spider washer , item# 47-2488-000-05 , lot# 3008333, affixus ph nl cap 0mm , item# 47-2488-010-00 lot# 3076782.Foreign source: japan.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 -2022 -00533, 0009613350 -2022 -00534, 0009613350 -2022 -00535, 0009613350 -2022 -00536.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.As neither products nor pictures of the products were returned, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing with a potential correlation to the reported event.Devices are used for treatment.Based on the investigation, it can be assumed that possible contributing factors contributing to the migration of the screw 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PROXIMAL HUMERUS, LEFT, 9X160MM
• Common Device Name: TRAUMA PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING SWITZERLAND GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER MANUFACTURING SWITZERLAND 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: 15602989
• Report Number: 0009613350-2022-00532
• Device Sequence Number: 11312841
• Product Code: HSB
• UDI-Device Identifier: 00889024505810
• UDI-Public: (01)00889024505810(17)310706(10)3078853
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181827
• 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): 02/09/2023

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 Model Number: N/A
• Device Catalogue Number: 47-2496-161-09
• Device Lot Number: 3078853
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male