MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	6118127090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine post-operative check-up using an x-ray, a foreign body was detected in the surgical field.The patient was reopened, and the blade fragment removed.It was also reported that the procedure was completed successfully without a clinically significant delay.
Additional Manufacturer Narrative
H6: a follow up report will be sent when the investigation is complete.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
No new information.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X90MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 23645819
• Report Number: 3015967359-2025-01684
• Device Sequence Number: 18672661
• Product Code: GFA
• UDI-Device Identifier: 04546540501417
• UDI-Public: (01)04546540501417(17)07/01/203(10)25193057
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 6118127090
• Device Lot Number: 25183057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown