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

Model Number	2107-3325
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Stryker drill bit #21073325 broke intra-operatively, all surgical team members aware of breakage.Two pieces retrieved immediately.

• Brand Name: INSTRUMENT
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP.; 325 corporate dr; mahwah NJ 07430
• MDR Report Key: 12421073
• Report Number: 12421073
• Device Sequence Number: 19711981
• Product Code: KWY
• UDI-Device Identifier: 07613327212358
• UDI-Public: (01)07613327212358
• 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): 08/19/2021
• Report Date (Section F): 08/19/2021

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: 2107-3325
• Device Catalogue Number: 2107-3325
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/19/2021