MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5MM CORT. SCREW 45MM LNG S; TRAUMA, SCREW

Catalog Number	47483504501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Loss of fracture reduction (4901)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item # 47493501003, one-third tubular plt 10 hole, lot # unknown.G2: foreign - event occurred in united kingdom.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.
Event or Problem Description
It was reported through a study database that a patient had a syndesmotic screw removed on the day of the initial procedure due to soft-tissue interposition preventing reduction with ongoing distal tibiofibular diastasis; the patient also developed a wound infection with a discharging sinus that required multiple courses of oral antibiotics.Only the screw was removed.Both events were considered possibly related to the procedure and the device.Both events resolved.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D4: product id was provided for two screws however, it is unknown which of the two screws was removed.Therefore, the screw removed could be any of the following: 47483504501 - 3.5mm cort.Screw 45mm lng s- 65271268.Udi: (b)(4).Manufacturing date: mar 25, 2022.Expiration date: mar 5, 2032.47483505001 - 3.5mm cort.Screw 50mm lng s- 65271270.Udi: (b)(4).Manufacturing date: feb 14, 2022.Expiration date: jan 24, 2032.D10: item # 47493501003, one-third tubular plt 10 hole, lot # unknown.Item # 47483505001, 3.5mm cort.Screw 50mm lng s, lot # 65271270.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d4, g3, g6, h2, h3, h6, h11 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for these items and the reported part and lot combination.Infection: during the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.Loss of bone reduction: 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.

• Brand Name: 3.5MM CORT. SCREW 45MM LNG S
• Common Device Name: TRAUMA, SCREW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24032069
• Report Number: 0001822565-2026-00126
• Device Sequence Number: 9141247
• Product Code: HRS
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2026

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: 47483504501
• Device Lot Number: 65271268
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/22/2026; 06/10/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/17/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 220 LB