MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP. INSTRUMENT; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 2107-3325

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2021

Event Type  malfunction  

Event Description

Stryker drill bit #21073325 broke intra-operatively, all surgical team members aware of breakage.Two pieces retrieved immediately.

• Brand Name: INSTRUMENT
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP.; 325 corporate dr; mahwah NJ 07430
• MDR Report Key: 12421073
• MDR Text Key: 269812594
• Report Number: 12421073
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07613327212358
• UDI-Public: (01)07613327212358
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2107-3325
• Device Catalogue Number: 2107-3325
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA