MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 7MM FEMORAL INDEX GUIDE; ACCESSORIES, ARTHROSCOPIC

Model Number 234-500-205

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 09/29/2022

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 the device broke and it was unable to be removed from the patient.

Manufacturer Narrative

Risk file does not have a risk line specifying allegation.An nc 3279144 is created for this.Manufacture date is not known.H3 other text : 81.

Event Description

It was reported that the device broke and it was unable to be removed from the patient.

• Brand Name: 7MM FEMORAL INDEX GUIDE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 16390539
• MDR Text Key: 309730333
• Report Number: 0002936485-2023-00130
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 234-500-205
• Device Catalogue Number: 234-500-205
• Device Lot Number: 131437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 07/07/2023
• 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
• Patient Age: 17 YR