MAUDE Adverse Event Report: STRYKER INSTRUMENTS BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	2008
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Stryker 2108 series sagittal blade tines (where it connects to handle, not patient saw end) broke off into the sterile field.Required a lot of time to identify where the metal fragment was from and after x-ray confirmation, the incision of arthroplasty had to be reopened to retrieve the fragment.Not only is this dangerous to the patient but arthroplasty implants are already very susceptible to infection and closure should be quick to reduce the risk.Much time was spent on locating and thankfully the patient was not hurt but had longer anesthesia time as a result.

• Brand Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 18641012
• Report Number: MW5151039
• Device Sequence Number: 8264041
• Product Code: GFA
• UDI-Device Identifier: 04546540042415
• UDI-Public: (01)04546540042415(17)281101(10)23318017
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/31/2024

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
• Operator of Device: Health Professional
• Device Model Number: 2008
• Device Lot Number: 23318017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White