MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. DISPOSABLE DRILL BIT, QC; BIT, SURGICAL

Catalog Number 310.35

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/10/2023

Event Type  malfunction  

Event Description

End of drill bit broke off while drilling into humeral plate.Remaining drill piece left in head of humerus by dr.

• Brand Name: DISPOSABLE DRILL BIT, QC
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 16466566
• MDR Text Key: 310505933
• Report Number: 16466566
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Sex: Female