MAUDE Adverse Event Report: STRYKER LEIBINGER GMBH & CO. KG STRYKER ISO PLATE SET; PLATE, BONE

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/21/2023

Event Type  malfunction  

Event Description

Patient was having a bunionectomy and osteotomy of the first left metatarsal.Podiatry resident, was drilling into the bone when the drill bit broke and imbedded into first metatarsal bone.The broken drill bit is fully imbedded and will not be removed per dpm.The drill bit is a part of the stryker iso plate set which was a loaner tray from stryker.

• Brand Name: STRYKER ISO PLATE SET
• Type of Device: PLATE, BONE
• Manufacturer (Section D): STRYKER LEIBINGER GMBH & CO. KG
• MDR Report Key: 16818249
• MDR Text Key: 314106045
• Report Number: MW5117068
• Device Sequence Number: 1
• Product Code: JEY
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American