MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 5AGITTAL BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	2108352000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that blade broke at the mount during a total joint procedure.It was further reported that there was an x-ray performed and a fragment of blade needed to be removed from the closed surgical site.It was also reported that there was no delay and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting confirmation of product return.
Event or Problem Description
It was reported that blade broke at the mount during a total joint procedure.It was further reported that there was an x-ray performed and a fragment of blade needed to be removed from the closed surgical site.The procedure was completed successfully without a clinically significant delay.
Additional Manufacturer Narrative
H2 correction for b5 - updated that there was a slight delay, but that this was not clinically significant.H2 device evaluation.H6: the quality investigation is complete.

• Brand Name: 5AGITTAL BLADE
• 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: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18658299
• Report Number: 3015967359-2024-00350
• Device Sequence Number: 8213082
• Product Code: GFA
• UDI-Device Identifier: 04546540042415
• UDI-Public: 04546540042415
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 05/28/2024

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: 2108352000
• Device Lot Number: 23318017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN HANDPIECE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown