MAUDE Adverse Event Report: ORTHO DEVELOPMENT; IMPACTOR

Model Number 270-5032

Device Problem Fracture (1260)

Patient Problem Arthralgia (2355)

Event Date 06/07/2019

Event Type  Injury  

Event Description

During hip arthroplasty when the surgeon was impacting the liner, the impactor broke into several pieces.The pieces were collected and the operation proceeded smoothly to completion.The surgeon reported impacting as usual, that the instrument may have deteriorated over the years, and that debris may remain inside the patient.No additional adverse consequences have been reported since the date of surgery.

• Type of Device: IMPACTOR
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper, ut
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper, ut
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, ut ; 5539991
• MDR Report Key: 10123875
• MDR Text Key: 195269995
• Report Number: 1722511-2020-00004
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 270-5032
• Device Lot Number: A109354
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2012
• 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