MAUDE Adverse Event Report: STRYKER CORP. / MAKO SURGICAL CORP. STRYKER NAVIGATION BONE PIN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 144170

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/28/2024

Event Type  malfunction  

Event Description

Navigation pin broke off in patient's pelvis (left side).No injury however pin head was retained in patient's pelvis.Provider chose to allow it to stay as no immediate damage/harm at this time.

• Brand Name: STRYKER NAVIGATION BONE PIN
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER CORP. / MAKO SURGICAL CORP.
• MDR Report Key: 19105082
• MDR Text Key: 340307887
• Report Number: MW5153841
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2024

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 Catalogue Number: 144170
• Device Lot Number: 48HL1223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White