MAUDE Adverse Event Report: Zimmer Biomet, Inc. 3.5X16MM CORT LOCK SCR STE; Orthopaedic bone screw, non-bioabsorbable, sterile

Catalog Number	856135016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Erythema (1840); Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after fixation with a plate system, erythema and purulent drainage developed around the plate and the patient reported discomfort; the plate was subsequently removed approximately five months post-implantation.Concerns were raised by sales and dealership staff regarding the hospital¿s sterilization and cleaning facilities; however, the validity of these concerns was unclear.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D6b: during june 2026.Item#: 856207006, fib anatomic lock rt 6h ste, lot#: 67288282, item#: 856210009, lock dist tib med rt 9h ste, lot#: 66808068, item#: 851235016, 3.5x16mm low pro cort scr ste, lot#: 882230, item#: 851235046, 3.5x46mm low pro cort scr ste, lot#: 024790, item#: 851235016, 3.5x16mm low pro cort scr ste, lot#: 882300, item#: 851235032, 3.5x32mm low pro cort scr ste, lot#: 774720, item#: 851235034, 3.5x34mm low pro cort scr ste, lot#: 986310, item#: 856135022, 3.5x22mm cort lock scr ste, lot#: 66340376, item#: 856135022, 3.5x22mm cort lock scr ste, lot # 67234418, item#: 856135024, 3.5x24mm cort lock scr ste, lot#: 65686163, item#: 856135024, 3.5x24mm cort lock scr ste, lot#: 65715436, item#: 856135026, 3.5x26mm cort lock scr ste, lot#: 67330015, item#: 856135038, 3.5x38mm cort lock scr ste, lot#: 67288256, item#: 856135042, 3.5x42mm cort lock scr ste, lot#: 476240, item#: 856135042, 3.5x42mm cort lock scr ste, lot # 67551110, item#: 856135046, 3.5x46mm cort lock scr ste, lot#: 155530, item#: 856135010, 3.5x10mm cort lock scr ste, lot#: 67340328, item#: 856135014, 3.5x14mm cort lock scr ste, lot#: 67340369, item#: 856135014, 3.5x14mm cort lock scr ste, lot#: 67367820, item#: 856135014, 3.5x14mm cort lock scr ste, lot#: 67405466, item#: 856135018, 3.5x18mm cort lock scr ste, lot#: 65685777, item#: 856135018, 3.5x18mm cort lock scr ste, lot#: 66772083, item#: 856135018, 3.5x18mm cort lock scr ste, lot#: 67222779, item#: 856135020, 3.5x20mm cort lock scr ste, lot#: 66884144.G2: foreign - event occurred in 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 3500a will be submitted.

• Brand Name: 3.5X16MM CORT LOCK SCR STE
• Common Device Name: Orthopaedic bone screw, non-bioabsorbable, sterile
• Manufacturer (Section D): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50430303
• Report Number: 0001825034-2026-02541
• Device Sequence Number: 10405552
• Product Code: HRS
• UDI-Device Identifier: 00887868351839
• UDI-Public: (01)00887868351839(17)350502(10)67210241
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 856135016
• Device Lot Number: 67210241
• 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: 07/26/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: See H11 narrative.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown