MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SHARPSHOOTER HANDLE; HOLDER, NEEDLE; ORTHOPEDIC

Model Number 4700

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 06/16/2023

Event Type  malfunction  

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 foreign material inside the sterile packaging.

• Brand Name: SHARPSHOOTER HANDLE
• Type of Device: HOLDER, NEEDLE; ORTHOPEDIC
• 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: 17339344
• MDR Text Key: 319331254
• Report Number: 0002936485-2023-00693
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 07613327375442
• UDI-Public: 07613327375442
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2023

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
• Device Operator: Health Professional
• Device Model Number: 4700
• Device Catalogue Number: 4700
• Device Lot Number: 00022339
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1