MAUDE Adverse Event Report: ZIMMSWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, LEFT, LONG, 8.5X220MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	N/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Unknown screw item # unknown, lot# unknown.Report source:foreign ¿ ¿japan".Multiple mdr reports were filed for this event, please see the associated reports: 0009613350-2023-00045.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.
Event or Problem Description
It was reported that two (2) weeks after initial surgery, the surgeon found one of the proximal screw was backed out from the proper position.Revision surgery is not planned, and the patient's condition will continue to be monitored.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).G2 ¿ foreign ¿ ¿japan".D10 - blunt tip screw 4x40mm item#47248604040, lot# 3078227.Blunt tip screw 4x42mm item# 47248604240, lot# 3054515.Blunt tip screw 4x44mm item# 47248604440, lot# 3024704.Torque screwdriver item, item# 27923, lot unknown.Multiple mdr reports were filed for this event, please see the associated reports: 0009613350-2023-00015, 0009613350-2023-00175, 0009613350-2023-00194.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that might be related to the reported event.Devices used for treatment.Medical records were not provided.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 locking mechanism of the 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 exact root cause could not be identified for the migration of the screw.If any further 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 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
It was reported that two (2) weeks after initial surgery, the surgeon found one of the proximal screw was backed out from the proper position.Revision surgery is not planned, and the patient's condition will continue to be monitored.Attempts have been made and no further information has been provided.

• Brand Name: PROXIMAL HUMERUS, LEFT, LONG, 8.5X220MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMSWITZERLAND 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: 16331866
• Report Number: 0009613350-2023-00015
• Device Sequence Number: 6419582
• Product Code: HSB
• UDI-Device Identifier: 00889024505933
• UDI-Public: (01)00889024505933(17)320201(10)3101637
• 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
• 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): 05/08/2023

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: 47-2496-221-08
• Device Lot Number: 3101637
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose