MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 65 DEGREE ANGLE PRECISION THIN OFFSET (10.5 X 0.38 X 13.7MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	2296003029
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text: device not returned.
Event or Problem Description
It was reported that during masseter surgery, the blade broke.It was also reported the fragment fell into the masseter wound near the parotid.It was further reported that the surgeon performed haemostasis and a repair to stop the bleeding.It was also reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during masseter surgery, the blade broke.It was also reported the fragment fell into the masseter wound near the parotid.It was further reported that the surgeon performed haemostasis and a repair to stop the bleeding.It was also reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The quality investigation is complete.Device not returned.

• Brand Name: 65 DEGREE ANGLE PRECISION THIN OFFSET (10.5 X 0.38 X 13.7MM)
• 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: 17548570
• Report Number: 3015967359-2023-01826
• Device Sequence Number: 6797211
• Product Code: GFA
• UDI-Device Identifier: 07613154511389
• UDI-Public: 07613154511389
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2296003029
• Device Lot Number: 23033017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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