MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TRAY AMISTEM-P; HIP SURGICAL INSTRUMENT

Device Problem Problem with Sterilization (1596)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2022

Event Type  malfunction  

Event Description

During the primary hip surgery when the amis stem pan was unwrapped, a hole was observed.Another pan was available that was also unwrapped, and a hole was also observed in the exact same location.The pan was put through sterilization to be used which caused a 30-minute delay.The surgery was completed successfully.

• Brand Name: TRAY AMISTEM-P
• Type of Device: HIP SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13803785
• MDR Text Key: 293712145
• Report Number: 3005180920-2022-00184
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/17/2022

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other