MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ANCHOR, PEEK, PUSH, 2.9 X 10MM

Catalog Number	MRPP2910
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)
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 "while dr.(b)(6) was suturing soft tissue the anchor became dislodged.The tip of the anchor looked bent.".
Additional Manufacturer Narrative
The customer reported receiving a medline push suture anchor, and while the surgeon was suturing soft tissue the anchor became dislodged and the tip looked bent; no injury was reported and the patient is fine.No sample/photo provided.The investigation included review of dhr, inspection records, recent complaint trends, and scar activity for the last three trend reports.Due to the incorrect lot number being provided, no abnormalities were found and the complaint could not be confirmed.No trends were identified for the material and defect type.The division will continue to monitor trends.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This mdr is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: ANCHOR, PEEK, PUSH, 2.9 X 10MM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50927226
• Report Number: 1417592-2026-52804
• Device Sequence Number: 9734239
• Product Code: MBI
• UDI-Device Identifier: 10193489104516
• UDI-Public: 10193489104516
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K193108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: MRPP2910
• Device Lot Number: 18187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/29/2026
• 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
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female