MAUDE Adverse Event Report: STRYKER CORP. STRYKER DRILL BIT

Model Number 1806-35405

Device Problem Break (1069)

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

Event Date 12/14/2018

Event Type  malfunction  

Event Description

Pt in surgery for total hip replacement.A stryker disposable drill bit broke off during the surgery.Broken piece retrieved and appeared to be intact.Surgeon aware.New drill bit obtained and surgery continued.No harm to the pt.

• Brand Name: STRYKER DRILL BIT
• Type of Device: DRILL BIT
• Manufacturer (Section D): STRYKER CORP.
• MDR Report Key: 8191375
• MDR Text Key: 131432189
• Report Number: MW5082498
• Device Sequence Number: 1
• Product Code: HTW
• 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: 12/19/2018

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 Expiration Date: 07/31/2018
• Device Model Number: 1806-35405
• Device Lot Number: KOC364C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2018
• 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: 84 YR
• Patient Weight: 73