MAUDE Adverse Event Report: STRYKER CORPORATION 12MM DRILL BIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 48328912

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/07/2023

Event Type  Injury  

Event Description

During surgery, the tip of the drill bit broke off into the c4 vertebral body; tip was left in place.

• Brand Name: 12MM DRILL BIT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER CORPORATION
• MDR Report Key: 17755624
• MDR Text Key: 323624011
• Report Number: MW5145674
• Device Sequence Number: 1
• Product Code: LXH
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48328912
• Device Catalogue Number: GTIN07613327267549
• Device Lot Number: 194817
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White