MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PIVOT GUARDIAN DIRECT FINE TRACTION; APPARATUS, TRACTION, NON-POWERED

Model Number 3105000306

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Hip Fracture (2349); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2022

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that there was patient injury of a broken femur that required an additional procedure to repair.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: patient injury of a broken femur.Probable root cause: design: poor connector designs or tolerancing, connector is loose, connector unable to hold force, unclear feedback if mechanism is fully locked/attached , casters slip on floor , vertical spars collapse , horizontal spars collapse, fine traction element pivots unintentionally , boot disconnects from fine traction element , tabletop extension cushion lifts or slides under force use error.The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

Event Description

It was reported that there was patient injury of a broken femur that required an additional procedure to repair.

• Brand Name: PIVOT GUARDIAN DIRECT FINE TRACTION
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16064387
• MDR Text Key: 306298354
• Report Number: 0002936485-2022-00799
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 07613327565379
• UDI-Public: 07613327565379
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3105000306
• Device Catalogue Number: 3105000306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other