MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IMPLANT KIT, ACHILLES REPAIR, 4.5MM

Catalog Number	MAKT4520
Medical Device Problem Codes	Fitting Problem (2183); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "using the provide drill guide and drill bit, upon drilling the first pilot hole - once the drill was approximately half the drill depth - the metal sleeve in the guide became cold-welded to the drill bit.In addition, the metal sleeve separated from the plastic portion of the guide.".
Additional Manufacturer Narrative
According to the customer, the metal sleeve in the guide became cold-welded to the drill bit and the metal sleeve separated from the plastic portion of the guide; the procedure was completed as planned using a back-up drill bit, and the implants/suture tape provided in the kit.Investigation included visual inspection of the picture received and review of recent complaint trends/scar activity for the last three trend reports.The complaint was confirmed, and per visual inspection of the picture received, the inner sleeve of disposable drill guide came out of the drill guide.The design of the instrument was reviewed, and it was concluded that the clearance between the drill shank and the drill bushing is tight; 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 medical device report (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 in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: IMPLANT KIT, ACHILLES REPAIR, 4.5MM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50843172
• Report Number: 1417592-2026-46702
• Device Sequence Number: 13249242
• Product Code: NWN
• UDI-Device Identifier: 10193489131703
• UDI-Public: 10193489131703
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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
• Device Catalogue Number: MAKT4520
• Device Lot Number: 19019
• 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: 10/20/2025
• Initial Report FDA Received Date: 09/21/2026
• 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 Sex: Unknown