MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP. AKA STRYKER ORTHOPAEDICS INSTRUMENT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 2107-2200

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

During tka a stryker flexible drill bit broke while in use.No injury to pt.All pieces removed from pt.

• Brand Name: INSTRUMENT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP. AKA STRYKER ORTHOPAEDICS; 325 corporate dr.; mahwah NJ 07430
• MDR Report Key: 6328708
• MDR Text Key: 67350177
• Report Number: 6328708
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2017

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: Physician
• Device Model Number: 2107-2200
• Device Catalogue Number: 2107-2200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR