MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PRECISION THIN RCP BLADE 0.010; BUR, EAR, NOSE AND THROAT

Model Number	5100437010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a jawbone osteotomy, the blade broke and a fragment remained in the patient, resulting in a thirty minute delay.It was also reported that the patient had a revision surgery to remove the blade fragment.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a jawbone osteotomy, the blade broke and a fragment remained in the patient, resulting in a thirty minute delay.It was also reported that the patient had a revision surgery to remove the blade fragment.It was further reported that the procedure was completed successfully.

• Brand Name: PRECISION THIN RCP BLADE 0.010
• Common Device Name: BUR, EAR, NOSE AND THROAT
• 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: 16532887
• Report Number: 3015967359-2023-00557
• Device Sequence Number: 12285350
• Product Code: EQJ
• UDI-Device Identifier: 07613327294576
• UDI-Public: 07613327294576
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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 Model Number: 5100437010
• Device Catalogue Number: 5100437010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Unknown