MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 7 X 25MM UNIVERSAL WEDGE INTERFERENCE SCREW; SCREW, FIXATION, BONE

Catalog Number	0234010052
Medical Device Problem Codes	Problem with Sterilization (1596); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there a breach in the sterile barrier.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
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: small gap in sterile.Packaging.Probable root cause: design.Improper packaging design.Application.Rough handling during shipping.The reported failure mode will be monitored for future reoccurrence h3 other text : 81.
Event or Problem Description
It was reported that there a breach in the sterile barrier.

• Brand Name: 7 X 25MM UNIVERSAL WEDGE INTERFERENCE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16922518
• Report Number: 0002936485-2023-00456
• Device Sequence Number: 6930881
• Product Code: HWC
• UDI-Device Identifier: 04546540754523
• UDI-Public: 04546540754523
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K972233
• 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,Followup
• Report Date (Section B): 09/12/2023

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
• Operator of Device: Other
• Device Catalogue Number: 0234010052
• Device Lot Number: 19234AG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• 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