MAUDE Adverse Event Report: ZIMMER GMBH ANN BLUNT TIP SCREW 4X54MM; IMPLANT, TRAUMA

Catalog Number	47-2486-054-40
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an initial surgery with ann nail.Subsequently, 9 days post implantation, surgeon found three of the proximal screws were backed out from the proper position.The surgeon will keep an eye on the patient condition as well, as no revision will be planned so far.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
(b)(4).D10.Ann blunt tip screw 4x48mm item# 47248604840 lot# 3221188.Ann blunt tip screw 4x50mm item# 47248605040 lot# 3228024.Ann ph nail rt 9x160mm item# 47249616009 lot# 3230675.Blunt tip screw, ã¿ 4x65mm item# 47248606540 lot# 3197006.Cortical bone screw, ã¿ 4x30mm item# 47248613040 lot# 3232072.Cortical bone screw, ã¿ 4x32mm item# 47248613240 lot# 3220939.Proximal humerus nail cap, 0mm item# 47248801000 lot# 3234492.G2.Report source: japan.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 will be submitted.
Additional Manufacturer Narrative
Follow up report.(b)(4).Updated: b4,b5,d2,g1,g3,g6,h1,h2,h3,h6.Corrected: d4.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 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.As the devices involved in the reported event were not returned for investigation, a further product evaluation could not be performed and it is not possible to test the assembly of the involved parts.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
No additional event information.

• Brand Name: ANN BLUNT TIP SCREW 4X54MM
• 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: 22586998
• Report Number: 0009613350-2025-00623
• Device Sequence Number: 18462242
• Product Code: HSB
• UDI-Device Identifier: 00889024505513
• UDI-Public: (01)00889024505513(17)280504(10)3157875
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K231114
• 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,Followup
• Report Date (Section B): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 47-2486-054-40
• Device Lot Number: 3157875
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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
• Patient Sex: Unknown