MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2108 SERIES SAGITTAL BLADE (18.6 X 0.64 X 61.1MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	2108120000
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported following a total hip replacement, the patient later presented with an infection.It was also reported that there was no medical intervention and no delays at the time of the surgery.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not returned.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H2: device not returned, no further information provided.H3 other text : device not returned.
Event or Problem Description
It was reported following a total hip replacement, the patient later presented with an infection.It was also reported that there was no medical intervention and no delays at the time of the surgery.It was further reported that the procedure was completed successfully.

• Brand Name: 2108 SERIES SAGITTAL BLADE (18.6 X 0.64 X 61.1MM)
• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16702658
• Report Number: 3015967359-2023-00701
• Device Sequence Number: 3628830
• Product Code: GFA
• UDI-Device Identifier: 04546540042071
• UDI-Public: 04546540042071
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/07/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2108120000
• Device Catalogue Number: 2108120000
• Device Lot Number: 22321017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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