MAUDE Adverse Event Report: ZIMMER GMBH ANN PH NAIL RT 7X160MM; Rod, Fixation, Intramedullary And Accessories

Catalog Number	47249616007
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from a retrospective clinical study that a patient had an initial intramedullary nailing of the right humerus.Subsequently, the patient underwent removal of all hardware approximately 7 months later due to nail prominence.X-rays revealed radiological protrusion without clinical symptoms.The patient remained satisfied throughout the study, and the bone had healed prior to explantation.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
(b)(4).D10.Blunt tip screw, 4x40mm item#: 47248604040 lot#: 3242834.Blunt tip screw, 4x40mm item#: 47248604040 lot#: 3240205.Blunt tip screw, 4x40mm item#: 47248604040 lot#: 3225016.Cortical bone screw, 4x26mm item#: 47248612640 lot#: 3232085.Cortical bone screw, 4x26mm item#: 47248612640 lot#: 3240161.Proximal humerus nail cap, 0mm item#: 47248801000 lot#: 3238233.G2: foreign - event occurred in spain.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4,b5,d2,g1,g3,g6,h1,h2,h3,h6 corrected: h1 complaint confirmed no product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.The reported products were reviewed for compatibility with no issues noted.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Radiographs were provided and reviewed by a radiologist.The review identified x-rays of the right shoulder dated both show fixation of comminuted fracture of surgical neck fixed with affixus natural nail proximal humeral system.At both visits, the intramedullary nail is seen to be not fully seated with the proximal end of the nail proud with respect to the humeral head.The later visit shows interval healing of the humeral neck fracture and apparent small focus of avascular necrosis of the humeral head.Medical records were provided and reviewed by a health care professional.The review identified on follow-up visit dated that patient took weekly non-narcotic pain meds and had mild tenderness to palpation.Patient overall and cosmetically satisfied.No instability, pain 6/10.Fracture healing ongoing, wound healed.X-rays show nail flush into joint at entry point.On (b)(6) 2025, pain was reduced to 4/10.No significant findings on xray.On (b)(6) 2026, patient stopped pain meds, mild tenderness to palpation was noted.Patient overall satisfied, feels she has some deltoid atrophy.No instability, pain 5/10.Fracture healed.X-rays show nail proud at entry point.Nail prominence, radiological protrusion without clinical protrusion.Nail covered with cartilage and was not mechanically irritating the rotator cuff.On (b)(6) 2026, nail and screws were removed.Satisfactory fluoroscopic control.No complications.Review of applicable surgical technique indicates that the proximal portion of the affixus natural nail should be inserted below the articular surface and at the level of subchondral bone once fully inserted.Based on the nail positioning section of the surgical technique of the affixus® natural nail® proximal humeral system, the proximal portion of the nail should be below the articular surface, and at the level of subchondral bone once fully inserted.Therefore, the root cause of the reported issue is attributed to an off label usage.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.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: ANN PH NAIL RT 7X160MM
• Common Device Name: Rod, Fixation, Intramedullary And Accessories
• 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: 24720093
• Report Number: 0009613350-2026-00200
• Device Sequence Number: 6088232
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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 Catalogue Number: 47249616007
• Device Lot Number: 3177555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 132 LB