MAUDE Adverse Event Report: DEPUY SYNTHES, INC. ANTERIOR CORAIL / TRI-LOCK STEM IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACCESSORIES)

Model Number PG270094

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2020

Event Type  malfunction  

Event Description

The end of a depuy, anterior corail / tri-lock impactor broke off during the procedure.Fda safety report id# (b)(4).

• Brand Name: ANTERIOR CORAIL / TRI-LOCK STEM IMPACTOR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACCESSORIES)
• Manufacturer (Section D): DEPUY SYNTHES, INC.
• MDR Report Key: 9805208
• MDR Text Key: 182894642
• Report Number: MW5093611
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/04/2020

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
• Device Model Number: PG270094
• Device Catalogue Number: PG270094
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2020
• 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 Age: 77 YR