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

Catalog Number	4700
Medical Device Problem Codes	Expiration Date Error (2528); Misfire (2532)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was reported to not be available for return.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: expired item used in case.Probable root cause: application failure to verify expiration status of product prior to surgery.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that an expired item was used in a case.

• Brand Name: SHARPSHOOTER HANDLE
• Common Device Name: 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: 22516327
• Report Number: 0002936485-2025-00642
• Device Sequence Number: 20821066
• Product Code: HXK
• UDI-Device Identifier: 07613327375442
• UDI-Public: 07613327375442
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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 Catalogue Number: 4700
• Device Lot Number: 00009326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown