MAUDE Adverse Event Report: STRYKER ENDOSCOPY DRILL BIT 2.5 LONG DRILL; BIT, DRILL

Catalog Number 703586

Device Problems Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/22/2020

Event Type  malfunction  

Event Description

A (b)(6) y/o male pt was taken to operating room on (b)(6) 2022 for open reduction and internal fixation of right tibial plateau fracture.The surgeon attempted to drill cortical screws into the tibial plate during the open reduction internal fixation when two drill bits were broken off into the bone.Surgeon determined that attempting to retrieve the broken fragments would cause more harm for the bone versus leaving them in place and that it would not after the pt's overall function.Surgeon provided disclosure to pt.Fda safety report id# (b)(4).

• Brand Name: DRILL BIT 2.5 LONG DRILL
• Type of Device: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY
• MDR Report Key: 9641698
• MDR Text Key: 177158115
• Report Number: MW5092586
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/27/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 703586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 50 YR
• Patient Weight: 68