MAUDE Adverse Event Report: ZIMMER GMBH NCB®, SCREW, SELF-TAPPING, ø 4.0 MM, 32 MM; IMPLANT, TRAUMA

Catalog Number	0203155032
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Unknown screw item# unknown lot# unknown.Ncbâ®, screw, self-tapping, 㸠4.0 mm, 32 mm item# 0203155032 lot# 3009474.Ncbâ®, screw, self-tapping, 㸠4.0 mm, 30 mm item# 0203155030 lot# 3012708.Ncb pp dis fem plt r12h l278mm item# 02.03264.012 lot# 3082932.G2.Report source: poland.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient needed a revision procedure due to fracture of the screw and an issue with the passage of the screw through the hole in the plate.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10, h11.The products involved in the reported event were returned for investigation.All three returned screws showed signs of use and wear/tear, with damage to the hex/head features, including scratching and gouging, and all three devices were fractured.The 32 mm screw (l/n 3009474) had damage along the upper edges and corners of the internal hex.The 30 mm screw (l/n 3012708) had damage to the upper edges of the hex feature.The third screw had no etch marking, so the lot and part information are unknown.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 and the items or the reported part and lot combination.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the entire right femoral operative site and hardware are not included.The visualized fixation plate is obliquely oriented and separated from the femur.The head of the most proximal screw is fractured and remains at the plate.The second screw is not fractured but the screw head has passed through the plate.The two most proximal fixation screws remain within the femur and the more distal screw is partially retracted from the femur.There is an incompletely visualized femoral fracture.Retracted proximal femoral fixation plate with proximal screw fracture and screw position as noted.The entire plate and screw fixation is not included on the image.The proximal screw is fractured and the second screw passes through the plate.On this limited image without complete visualization of the femoral fracture and fixation hardware, trauma to cause the screw facture cannot be determined.A definitive root cause cannot 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
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: NCB®, SCREW, SELF-TAPPING, ø 4.0 MM, 32 MM
• 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: 24277136
• Report Number: 0009613350-2026-00043
• Device Sequence Number: 13227130
• Product Code: HSB
• UDI-Device Identifier: 00889024296176
• UDI-Public: (01)00889024296176(10)3009474
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 03/25/2026

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: 0203155032
• Device Lot Number: 3009474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2019
• 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 Sex: Unknown