MAUDE Adverse Event Report: Centurion Medical Products., LP CENTURION; CIRCUMCISION TRAY

Catalog Number	CIT2590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the scissors were broken during use.They separated.".
Additional Manufacturer Narrative
The customer reported finding broken scissors, and the complaint stated that the scissors separated during use with no patient harm.The investigation noted that no sample or photo was received, finished good production records were reviewed with no line down situations, run without approvals, deviations, or non-conformance reports that might have had an impact, and the finished good pack build was reviewed with no issues that likely contributed to the reported issue.The reported issue was unable to be confirmed due to no sample or photo being received.With the information provided, medline was not able to confirm at what point the damage occurred or what may have caused it, and the division will monitor for trending purposes.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: CENTURION
• Common Device Name: CIRCUMCISION TRAY
• Manufacturer (Section D): Centurion Medical Products., LP; 301 catrell drive; howell MI 48843 -170
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884359
• Report Number: 1824619-2026-00100
• Device Sequence Number: 15909282
• Product Code: OHG
• UDI-Device Identifier: 00653160020656
• UDI-Public: 00653160020656
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/23/2026

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: CIT2590
• Device Lot Number: 22LBH173
• Was Device Available for Evaluation?: Yes
• 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: 04/10/2023
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown