MAUDE Adverse Event Report: ZIMMER GMBH CORTICAL BONE SCREW, ÿ 4X20MM; IMPLANT, TRAUMA

Catalog Number	47248612040
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
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.
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.Blunt tip screw, ã¿ 4x34mm item# 47248603440, lot# 3091447.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.
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 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
The following sections were updated/corrected: this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h11.Upon reassessment of the reported event, it was determined to be not reportable as it was confirmed that the reported event was unrelated to the reported zb device.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable as it was confirmed that the reported event was unrelated to the reported zb device.The initial report was forwarded in error and should be voided.

• Brand Name: CORTICAL BONE SCREW, ÿ 4X20MM
• Common Device Name: IMPLANT, TRAUMA
• 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: 22169777
• Report Number: 0009613350-2025-00409
• Device Sequence Number: 9209385
• Product Code: HSB
• UDI-Device Identifier: 00889024505308
• UDI-Public: (01)00889024505308(17)270817(10)3126149
• 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 Catalogue Number: 47248612040
• Device Lot Number: 3126149
• 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): No
• Date Device Manufactured: 08/17/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 75 KG