MAUDE Adverse Event Report: STRYKER SPINE-US ES2 LE NITINIOL KWIRE BLUNT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48280232
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of q1 2023 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures five instances of intraoperative es2 le nitiniol kwire tip fracture.
Additional Manufacturer Narrative
Lot unknown (3): device not returned.Lot unknown (2): device returned 12 april 2023.
Additional Manufacturer Narrative
Lot unknown (3): device not returned; lot unknown (1): manufacture date 22 september 2022, device returned 12 april 2023; lot b153735 (1): device returned 12 april 2023.
Event or Problem Description
This record is a consolidation of q1 2023 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures five instances of intraoperative es2 le nitiniol kwire tip fracture.

• Brand Name: ES2 LE NITINIOL KWIRE BLUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 16838119
• Report Number: 0009617544-2023-00018
• Device Sequence Number: 7547275
• Product Code: LXH
• UDI-Device Identifier: 07613327096200
• UDI-Public: 07613327096200
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 5
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2023

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: Health Professional
• Device Model Number: 48280232
• Device Catalogue Number: 48280232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2023
• Supplement Date Received by Manufacturer: 07/01/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown