MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP. TRIDENT II; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	7030-6525
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Attending surgeon utilized stryker screw size 6.5 mm low diameter and 25mm length profile hex screw ref # (b)(4) in right acetabulum when operating on right hip.At this time, head of this screw broke off.

• Brand Name: TRIDENT II
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP.; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 14111189
• Report Number: 14111189
• Device Sequence Number: 2096390
• Product Code: LPH
• UDI-Device Identifier: 07613327345001
• UDI-Public: (01)07613327345001
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/25/2022
• Report Date (Section F): 03/25/2022

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
• Operator of Device: Health Professional
• Device Model Number: 7030-6525
• Device Catalogue Number: 7030-6525
• Device Lot Number: XNGA
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 03/25/2022