MAUDE Adverse Event Report: ZIMMER GMBH ANN BLUNT TIP SCREW 4X44MM; Rod, Fixation, Intramedullary And Accessories

Catalog Number	47-2486-044-40
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Aseptic loosening (4883)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: desc: ann ph nail rt 9x160mm; item: 47-2496-160-09; lot: 3223706.G2: report source: spain.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 from a clinical study that a patient had underwent im nailing of the right proximal humerus.Subsequent x-rays revealed evidence of proximal screw loosening and protrusion.The patient is scheduled for screw removal on an unknown date due to pain from the protruded screw.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b7, d4, g3, g6, h1, h2, h3, h4, h6, h10, h11.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 surgical technique explains that the locking of the corelock is done using the corelock driver with torque limiting handle."turn slowly clockwise to tightenand engage the corelock mechanism until a click is felt from the torque limiting handle.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.Complaints are monitored in order to identify potential adverse trends.Medical records were provided and reviewed by a health care professional.The patient underwent intramedullary nailing of the right proximal humerus on (b)(6)2026.Fixation was reported as satisfactory under intraoperative fluoroscopy; however, the clinical record indicated proximal screw protrusion on immediate postoperative radiographs.On (b)(6)2026, the patient reported worsening pain and a sensation that something was displaced; no surgical wound or extremity concerns were identified, and no concerns were noted on the radiographs reviewed at that visit.Rehabilitation notes indicated that mild pain had improved with analgesics and home exercises.On (b)(6), 2026, the patient reported worsening symptoms after an initial period of improvement.Tenderness over the anteromedial screw head and pain-limited range of motion were documented, and radiographs showed proximal screw loosening.Proximal screw removal was scheduled for (b)(6) 2026 a definitive root cause could not be determined.However, based on the investigation it could be assumed that possible contributing factors to the migration of the screw might 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.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.An additional deeper investigation was performed which identified the design limitation of the corelock mechanism as a potential contributing factor.However, as further biomechanical testing was carried out and the performance is in an acceptable range in comparison with legally marketed similar devices, no design changes were conducted.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.

• Brand Name: ANN BLUNT TIP SCREW 4X44MM
• 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: 25030396
• Report Number: 0009613350-2026-00230
• Device Sequence Number: 21397568
• Product Code: HSB
• UDI-Device Identifier: 00889024505469
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: 47-2486-044-40
• Device Lot Number: 3265431
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2026
• 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: Other
• Patient Sex: Female
• Patient Weight: 209 LB