MAUDE Adverse Event Report: ZIMMER GMBH ANN BLUNT TIP SCREW 4X50MM; IMPLANT, TRAUMA

Catalog Number	47248605040
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Ann ph nail rt 10x220mm item# 47249622009 lot# 3174907.Ann blunt tip screw 4x50mm item# 47248605040 lot# 3228198.Ann blunt tip screw 4x52mm item# 47248605240 lot# 3076792.Blunt tip screw, ã¿ 4x52mm item# 47248605240 lot# 3207865.Blunt tip screw, ã¿ 4x54mm item# 47248605440 lot# 3157875.Cortical bone screw, ã¿ 4x28mm item# 47248612840 lot# 3240162.Cortical bone screw, ã¿ 4x30mm item# 47248613040 lot# 3225546.Proximal humerus nail cap, 0mm item# 47248801000 lot# 3242939.G2.Report source: japan.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 the part and lot combinations.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Radiographs were provided and reviewed by a radiologist.The review identified the following: photo of a computer screen showing a fluoroscopic ap image of the proximal humerus with five interlocking screws.Intramedullary nail in the humerus spanning what appears to be a proximal humeral metadiaphysis fracture.Three of the screw heads are proud with substantial backout of the proximal screw.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.It can be assumed that multiple contributing factors, related to either patient condition and behavior or implantation procedure, contributed to the migration of the screws.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.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 that operation was performed with ann nail.One week after the initial surgery, surgeon found one of the proximal screws was backed out from the proper position.Two weeks after the initial surgery, all of the proximal screws were backed out from the proper position and subsequently underwent a revision surgery, during which, the surgeon confirmed that the corelock had become loose.Then the screw depth was readjusted, the corelock was retightened, and the revision was completed.Diligence is completed and no further information on the reported event has been provided.

• Brand Name: ANN BLUNT TIP SCREW 4X50MM
• Common Device Name: IMPLANT, TRAUMA
• 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: 23074155
• Report Number: 0009613350-2025-00706
• Device Sequence Number: 4748803
• Product Code: HSB
• UDI-Device Identifier: 00889024505490
• UDI-Public: (01)00889024505490(17)300219(10)3228024
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 09/17/2025

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: 47248605040
• Device Lot Number: 3228024
• 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: 08/22/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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 Sex: Unknown