MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION MIS EXTRACTOR SLAP HAMMER

Model Number 9303-5301

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2020

Event Type  malfunction  

Event Description

During total left knee arthroplasty an instrument called a "slap hammer" became loose, feel apart on the welded portion.No patient harm.No x-ray needed.Fda safety report id# (b)(4).

• Brand Name: MIS EXTRACTOR SLAP HAMMER
• Type of Device: EXTRACTOR
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; irvine CA 92618
• MDR Report Key: 9915576
• MDR Text Key: 186304115
• Report Number: MW5094012
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9303-5301
• Device Catalogue Number: 9303-5301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR