MAUDE Adverse Event Report: PARAGON 28 SUTR ANCHOR ALL-SUTR 1.4MM STRL KIT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	P44-210-0014-SK
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: sutr anchor all-sutr 1.4mm strl kit cat #: p44-210-0014-sk, lot #: 5010540.H6: proposed component code: mechanical (g04) - drill.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 that during an orthopedic procedure 2 instrument fractured, and the debris remains in the patient with no known impact or consequence reported at the time of the event.No additional patient treatment beyond intraoperative imaging and retrieval attempts was reported.There were no known complications reported at the time, and no immediate revision was reported.Attempts have been made, and no further information has been provided.
Event or Problem Description
It was reported that during an orthopedic procedure 2 instrument fractured, and the debris remains in the patient with no known impact or consequence reported at the time of the event.No additional patient treatment beyond intraoperative imaging and retrieval attempts was reported.There were no known complications.There was an intra-operative delay of less than approximately 30 minutes.The patient had retained metal fragments with no known side effects, and no revision was required.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2b, d4, d9, g3, g6, h4, h5, h6 d10: part p44-210-0014-sk, sutr anchor all-sutr 1.4mm strl kit, lot 5010540.The reported event was confirmed by review of radiographs.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single intraoperative fluoroscopic image shows a fractured drill bit tip within the distal fibula.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found 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: SUTR ANCHOR ALL-SUTR 1.4MM STRL KIT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 23682334
• Report Number: 3008650117-2025-00013
• Device Sequence Number: 15893005
• Product Code: GAT
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K211002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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
• Device Catalogue Number: P44-210-0014-SK
• Device Lot Number: 5010540
• 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: 11/08/2025
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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: 53 YR
• Patient Sex: Female