MAUDE Adverse Event Report: ZIMMER GMBH ANN BLUNT TIP SCREW 4X48MM; IMPLANT, TRAUMA

Catalog Number	47-2486-048-40
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Aseptic loosening (4883)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D4: product id was provided for two screws; however, it is unknown which of the screws was related to the event.Therefore, the screw could be any of the following: 47248605240 ¿ blunt tip screw ¿ 3024744, udi: (b)(4), manufacturing date: apr 28, 2020.Expiration date: mar 31, 2025.47248604840 ¿ blunt tip screw ¿ 3205625, udi: (b)(4), manufacturing date: jun 5, 2024.Expiration date: jun 6, 2029.D10: 47249628008¿ proximal humerus, right, long ¿ 3026741, 47248604840 ¿ blunt tip screw ¿ 3205625, 47248612640 ¿ cortical bone screw ¿ 3204761, 47248612640 ¿ cortical bone screw ¿ 3209520, 47248801000 ¿ proximal humerus nail cap ¿ 3208165, therapy date: (b)(6) 2025.G2: foreign country spain.Attempts have been made to gather all product identification information and no further information has been provided.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 that patient underwent a revision approximately 4 months post implantation due to loosening of proximal head screw.The subject is reported as improved/recuperated 5 months later.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, b6, d2, e1, g1, g3, g6, h1, h2, h6.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
It was reported from a clinical study that a patient had an orif of the right proximal humerus.Subsequently, the patient underwent removal of a proximal screw 4 months post implantation due to pain and loosening.No further complications were reported.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
Follow up report (b)(4).Updated: b4,b5,d2,d9,g1,g3,g6,h1,h2,h3,h4,h6 corrected: d1,d4,d10.D10: 47249628008¿ proximal humerus, right, long ¿ 3026741, 47248605240 ¿ blunt tip screw ¿ 3024744, 47248612640 ¿ cortical bone screw ¿ 3204761, 47248612640 ¿ cortical bone screw ¿ 3209520, 47248801000 ¿ proximal humerus nail cap ¿ 3208165.Therapy date: (b)(6) 2025.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 that could be related to the reported event.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.Medical records were provided and reviewed by a health care professional.The surgical report of the revision describes the following, incision on the prominence of osteosynthesis material at the right proximal humerus, removal.Radiographs were provided and reviewed by a radiologist.The review identified the following: spot digital radiographic image of the right humerus, with humeral head internally rotated, reveals presence of an acute spiral fracture of the proximal humeral shaft, fixed with intramedullary nail and 2 proximal interlocking screws.Only the proximal humerus is included on this single view.Hardware appears intact.One year after the first radiographs, radiographs of the right humerus (2 views) show presence of right humeral spiral fracture which exhibits probable bridging bone partially spanning the fracture site.This fracture is fixed with intramedullary nail, 2 proximal interlocking screws within the humeral head, and 2 distal interlocking screws at the distal humeral diametaphysis.Hardware appears intact.However, radiolucent lines are present at the 1st and 2nd proximal interlocking screw metal-bone interfaces, consistent with screw loosening.Additionally, the second of the proximal interlocking screws is not fully embedded in bone and appears to have backed out of the humerus, with approximately 25% of the screw length now external to bone and approximately 75% of the screw length still embedded within bone.A slight metal shedding projects at the proximal interlocking screw-nail intersection.Bones appear to be generally osteopenic.The radiology and surgical reports indicate that the patient sustained a spiral fracture of the right proximal humerus that was stabilized with an intramedullary nail and interlocking screws.Follow-up imaging shows partial healing with some bone bridging but also signs of screw loosening and partial screw backing out, suggesting instability.Surgical removal of the loosened screw was therefore performed.As the devices involved in the reported event were not returned for investigation, a further product evaluation could not be performed and the condition of the products are unknown.In conclusion, as the cause may be multifactorial, an exact root cause could not be identified for the loosening/backing out of the screw.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.

• Brand Name: ANN BLUNT TIP SCREW 4X48MM
• 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 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22167672
• Report Number: 0009613350-2025-00399
• Device Sequence Number: 15400964
• Product Code: HSB
• UDI-Device Identifier: 00889024505483
• UDI-Public: (01)00889024505483(17)290606(10)3205625
• 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: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2025

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: 47-2486-048-40
• Device Lot Number: 3205625
• 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: 07/01/2025; 10/17/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/21/2025; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 91 KG