MAUDE Adverse Event Report: ZIMMER GMBH BLUNT TIP SCREW, ÿ 4X40MM; TRAUMA, PLATE, SCREW

Catalog Number	47248604040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): g2: report source switzerland.D4: product id was provided for four screws; however, it is unknown which of the four screws has explanted.Therefore, the explanted screw could be any of the following: 47248604040 - blunt tip screw, ã¿ 4x40mm- (b)(6), udi: (b)(4), manufacturing date: mar 20, 2023, expiration date: mar 20, 2028.47248603840 - blunt tip screw, ã¿ 4x38mm - (b)(6), udi: (b)(4), manufacturing date: nov 25, 2020, expiration date: oct 31, 2025.47248612240 - cortical bone screw, ã¿ 4x22mm - (b)(6), udi: (b)(4), manufacturing date: may 2, 2023 expiration date: may 2, 2028 47248604640 - blunt tip screw, ã¿ 4x46mm - (b)(6), udi: (b)(4), manufacturing date: jun 24, 2026, expiration date: jun 24, 2021.D10: item # 47248603840, blunt tip screw, ã¿ 4x38mm, lot # 3054317, item # 47248612240, cortical bone screw, ã¿ 4x22mm, lot # 3157868, item # 47248604640, blunt tip screw, ã¿ 4x46mm, lot # 3076745, item # 47248801000, proximal humerus nail cap, 0mm, lot # 3010700, item # 47249620007, proximal humerus, right, long, ã¿ 7x200mm, lot # 3007834.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 patient was originally implanted with the affixus humeral nail, approximately 10 months post implantation patient underwent removal of a screw due to unknown symptoms.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, 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.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.A definitive root cause could not be determined.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 event information available at the time of this report.

• Brand Name: BLUNT TIP SCREW, ÿ 4X40MM
• Common Device Name: TRAUMA, PLATE, SCREW
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• 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: 21921218
• Report Number: 0009613350-2025-00348
• Device Sequence Number: 21103837
• Product Code: HSB
• UDI-Device Identifier: 00889024505445
• UDI-Public: (01)00889024505445(17)280320(10)3152714
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 47248604040
• Device Lot Number: 3152714
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 62 KG