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

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.

Event 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.

Manufacturer Narrative

H6: the quality investigation is complete.

Event 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
• Type of Device: 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
• MDR Text Key: 311248166
• Report Number: 3015967359-2023-00557
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 07613327294576
• UDI-Public: 07613327294576
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention