MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE FEMORAL INS/REM IMPACTOR HEAD; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSR100931
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an instrument tray reprocessing, it was found that the stride femoral impactor was cracked.No case involved.

• Brand Name: STRIDE FEMORAL INS/REM IMPACTOR HEAD
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES
• MDR Report Key: 11008941
• Report Number: 3010266064-2020-02110
• Device Sequence Number: 3814081
• Product Code: OLO
• UDI-Device Identifier: 00885556627334
• UDI-Public: 00885556627334
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

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: PFSR100931
• Device Catalogue Number: PFSR100931
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/15/2020
• Patient Sequence Number: 1