MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER UNIVERSAL LOCKING SYSTEM LOCKING RECONSTRUCTION PLATE STRAIGHT; SCREW, FIXATION, BONE

Catalog Number	47493600713
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an initial implantation approximately one (1) year and five (5) months ago due to pelvic fracture.During implantation, patient received 2 plates and 8 screws.Subsequently, patient had a follow-up visit more than four (4) months post-implantation where it was discovered that one of the plates fractured.Patient did not experience any discomfort at this time; therefore, the surgeon opted to not revise at this time.Patient later underwent an implant removal surgery approximately one (1) year and four (4) months post-implantation as a planned part of healing being completed where the fractured plate, along with the remaining plates and screws, were successfully removed.Patient had no adverse reactions as a result of the event.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10: item# straight locking plate, 10-hole, 131mm; lot# unknown, item# locking screws 3.524mm; lot# unknown, item# locking screws 3.524mm; lot# unknown, item# cortical bone screws 3.5×28mm; lot# unknown, item# cortical bone screws 3.5×28mm; lot# unknown, item# locking screws 3.5×22mm; lot# unknown, item# locking screws 3.5×22mm; lot# unknown, item# cortical bone screws 3.5×26mm; lot# unknown, item# cortical bone screws 3.5×26mm; lot# unknown.E1: full establishment name - (b)(6).G2: foreign - event occurred in india.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIMMER UNIVERSAL LOCKING SYSTEM LOCKING RECONSTRUCTION PLATE STRAIGHT
• Common Device Name: SCREW, FIXATION, BONE
• 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: 24085838
• Report Number: 0001822565-2026-00185
• Device Sequence Number: 5879142
• Product Code: HWC
• UDI-Device Identifier: 00889024104143
• UDI-Public: (01)00889024104143(17)311130(10)47493600713
• 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: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: 47493600713
• Device Lot Number: 65267913
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11
• Patient Age: 28 YR
• Patient Sex: Male