MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS, INC. ORTHOPEDIC TRAY

Catalog Number	UIOT55
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of investigation.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.
Event or Problem Description
Customer found foreign material in packs which caused a 54 min delay in procedure.Debris was discovered prior to case start, requiring new set up.No other patient impact indicated.
Additional Manufacturer Narrative
The device history record for complaint lot was reviewed, there were no issues found.Cleaning logs were reviewed, no contributing issues were detected.Likely root cause was assembly teammate failed to properly perform gowning sequence and hair was missed during kit verification.A quality alert was issued stressing importance of complaint incident.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.

• Brand Name: ORTHOPEDIC TRAY
• Common Device Name: ORTHOPEDIC TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 1601 se gateway drive; ste 120; grimes IA 50111
• Manufacturer (Section G): AMERICAN CONTRACT SYSTEMS; 1601 se gateway drive; suite 120; grimes IA 50111
• Manufacturer Contact: nichole coggins ; 1601 se gateway drive; suite 120; grimes, IA 50111 ; 8287820529
• MDR Report Key: 20230413
• Report Number: 3007069947-2024-00002
• Device Sequence Number: 21061004
• Product Code: OJH
• UDI-Device Identifier: 00191072217431
• UDI-Public: 00191072217431
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: UIOT55
• Device Lot Number: 42-7845311
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/01/2024
• 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
• Patient Sex: Unknown