MAUDE Adverse Event Report: AEQUALIS ASCEND FLEX TRAY TRIAL; ORTHOPAEDIC MANUAL SURGICAL INSTRUMENT

Model Number	TH +0 ECC HIGH 3.5
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
Tray sheared off inside the compactor for no obvious reason.Backup device used.Delay in surgery the time to retrieve alternative instruments.

• Brand Name: AEQUALIS ASCEND FLEX TRAY TRIAL
• Common Device Name: ORTHOPAEDIC MANUAL SURGICAL INSTRUMENT
• MDR Report Key: 9710848
• Report Number: 3000931034-2020-00016
• Device Sequence Number: 3603205
• Product Code: LXH
• UDI-Device Identifier: 03700386977008
• UDI-Public: 03700386977008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: TH +0 ECC HIGH 3.5
• Device Catalogue Number: MWF520S
• Device Lot Number: 15D311
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR