MAUDE Adverse Event Report: ZIMMER GMBH BLUNT TIP SCREW, ÿ 4X34MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	47248603440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Proximal humerus, left, long, ã¿ 7x220mm item# 47249622107, lot# 3127391 blunt tip screw, ã¿ 4x34mm item# 47248603440, lot# 3091296.Cortical bone screw, ã¿ 4x20mm item# 47248612040, lot# 3126149.Cortical bone screw, ã¿ 4x22mm item# 47248612240, lot# 3152713.Proximal humerus nail cap, 0mm item# 47248801000, lot# 3151018.G2.Report source: 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.
Event or Problem Description
It was reported that the patient had an initial procedure with affixus humeral nail system.Subsequently, experienced nail protrusion with impingement symptoms and approximately one year post implantation underwent a revision surgery when the device was removed.Due diligence is in process and no further information on the reported event has been provided.
Event or Problem Description
It was reported that a patient had an initial orif of the left humerus.Subsequently, the site reported nail protrusion with impingement symptoms.The patient underwent hardware removal, approximately 10 months post implantation, with repair of a partial rotator cuff injury.No complications or allegations against hardware were reported.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a3, b3, b4, b5, b7, d6b, g3, g6, h2, h6, h10, h11.
Event or Problem Description
It was reported from a clinical study that the patient underwent an initial open reduction and internal fixation of the left humerus on an unknown date.Approximately 3 months post-implantation, the site reported nail protrusion with impingement symptoms.Approximately 10 months post-implantation, the patient underwent complete hardware removal with concurrent repair of a partial rotator cuff injury.The site reported the event as a serious adverse event and assessed it as not related to the device, causal to the surgical procedure, and not related to instruments.No intraoperative complications or environmental factors were reported.The patient was reported as improved/recuperated subsequently.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a4; b5; d2a; d8; e1; g3; g6; h2; h3; h6; h10; h11.The reported event was confirmed by review of x-rays.Radiographic imaging was reviewed by a radiologist and included a single intraoperative fluoroscopic image along with two follow-up studies featuring anteroposterior (ap) and scapular y views of the left humerus.Radiographic review showed the intramedullary nail positioned proud of the humeral articular surface, with this alignment unchanged during follow-up.Progressive back-out of the proximal interlocking screw was observed, which may have contributed to soft tissue irritation or impingement.No direct hardware-related complications were documented.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as an initial incorrect alignment of the nail relative to humerus.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: BLUNT TIP SCREW, ÿ 4X34MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22169767
• Report Number: 0009613350-2025-00407
• Device Sequence Number: 9208910
• Product Code: HSB
• UDI-Device Identifier: 00889024505421
• UDI-Public: (01)00889024505421(17)260924(10)3091447
• 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: 2023
• Device Explanted Year: 2024
• 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,Followup,Followup
• Report Date (Section B): 10/28/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/24/2026
• Device Catalogue Number: 47248603440
• Device Lot Number: 3091447
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 10/27/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/08/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 75 KG