MAUDE Adverse Event Report: ZIMMER GMBH PROXIMAL HUMERUS, RIGHT, ÿ 9X160MM; TRAUMA, PLATE

Catalog Number	47249616009
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4(: d10: item # 47248604640, blunt tip screw, ã¿ 4x46mm, lot # 3238245, item # 47248604840, blunt tip screw, ã¿ 4x48mm, lot # 3225538, item # 47248603440, blunt tip screw, ã¿ 4x34mm, lot # 3207877, item # 47248604640, blunt tip screw, ã¿ 4x46mm, lot # 3238245, item # 47248613440, cortical bone screw, ã¿ 4x34mm, lot # 3187130, item # 47248800005, spider washer, lot # 3068433, item # 47248800004, washer small, lot # 3217676.G2: report source japan.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.Radiographs were provided and reviewed by a radiologist.The review identified intramedullary nail fixation of markedly comminuted right proximal humerus fracture.The 4- and 6-week follow-up images show loosening and backout of 2 of the proximal locking screws.Medical records were provided and reviewed by a health care professional.The review identified proximal fracture of the left (contralateral) humerus, weekly non-narcotic pain medication, no tenderness at fracture site, overall satisfied.No instability, moderate pain 4/10, wound healed.Screw loosening, mild, no treatment at this time.It can be assumed that multiple contributing factors, related to either patient condition and behavior or implantation procedure, contributed to the migration of the screws.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations 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, ascientific 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
It was reported from a clinical study that the patient underwent an initial right proximal humeral nailing, and screw loosening was incidentally identified on radiographs approximately 6 weeks post-implantation.Subsequently, the patient experienced a fall and sustained a fracture of the left humerus; the left side had no implants and was managed conservatively without surgical intervention.During the next follow-up visit approximately 3 weeks later, radiographs showed loosening of a second screw, while the first screw remained unchanged.No action was taken as the patient was not reporting pain or discomfort.The patient did not require surgical intervention and remained asymptomatic.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: PROXIMAL HUMERUS, RIGHT, ÿ 9X160MM
• Common Device Name: TRAUMA, PLATE
• Manufacturer (Section D): ZIMMER 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24729273
• Report Number: 0009613350-2026-00202
• Device Sequence Number: 9286967
• Product Code: HSB
• UDI-Device Identifier: 00889024505780
• UDI-Public: (01)00889024505780(17)350321(10)3230672
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 47249616009
• Device Lot Number: 3230672
• 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: 10/06/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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 H11 NARRATIVE
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 88 KG