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

Model Number PFSR100931

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2020

Event Type  malfunction  

Event 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
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11008941
• MDR Text Key: 221519758
• Report Number: 3010266064-2020-02110
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556627334
• UDI-Public: 00885556627334
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR100931
• Device Catalogue Number: PFSR100931
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1