MAUDE Adverse Event Report: PARAGON 28 R3CON LKNG PLT SCW 3.5X24MM; SCREW, FIXATION, BONE

Catalog Number	P50-353-3524
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two 3.5 mm screws were found fractured at the mid-shaft during a scheduled removal, requiring intra-operative retrieval with a removal set.The screws had not been identified as broken prior to the removal.The broken shafts were fully extracted using the operative removal set, which added approximately 20 to 30 minutes to the surgery.There were no known impacts or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10 concomitant products (all lots unknown): 1 ea p53-109-r113, med clmn dstl arch plt 2.0mm thk r lg, 1 ea p53-110-r002, lisfranc slntd-t 5-hl plt w/ comp rt, 1 ea p20-135-030s, can sht thd scw hd 3.5x30mm, 1 ea p50-353-3514, r3con lkng plt scw 3.5x14mm, 1 ea p50-353-3516, r3con lkng plt scw 3.5x16mm, 1 ea p50-353-3518, r3con lkng plt scw 3.5x18mm, 1 ea p50-353-3520, r3con lkng plt scw 3.5x20mm, 2 ea p50-353-3532, r3con lkng plt scw 3.5x32mm, 2 ea p50-453-3530, r3con n-lkng plt scw 3.5x30mm, 1 ea p50-453-3540, 3.5 x 40 mm r3con non-locking plate screw.G2: foreign - event occurred in australia.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: R3CON LKNG PLT SCW 3.5X24MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): PARAGON 28; 14445 grasslands dr.; englewood CO 80112
• Manufacturer (Section G): PARAGON 28; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25659431
• Report Number: 3008650117-2026-00342
• Device Sequence Number: 17552344
• Product Code: HWC
• UDI-Device Identifier: 00889795016522
• UDI-Public: (01)00889795016522(10)MM2505645
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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: Health Professional
• Device Catalogue Number: P50-353-3524
• Device Lot Number: MM2505645
• 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: 06/10/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Patient Age: 33 YR
• Patient Sex: Male