MAUDE Adverse Event Report: STRYKER INSTRUMENTS FORMULA; BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL

Model Number	0375545000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure while the surgeon was using the stryker arthroscopic shaver, the blade (ref# 0375-545-000, lot # 22052ce2) was noted to be shedding metal debris.The surgical site was thoroughly irrigated.Shavers with the same lot number were all removed from inventory by staff.Manufacturer response for blade, saw, general plastic surgery, surgical, formula (per site reporter).All shavers with the same lot number were removed from inventory and the stryker rep was notified of the issue.

• Brand Name: FORMULA
• Common Device Name: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 15282296
• Report Number: 15282296
• Device Sequence Number: 7054211
• Product Code: GFA
• UDI-Device Identifier: 37613327061797
• UDI-Public: (01)37613327061797(17)270220(10)22052CE2
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/12/2022
• Report Date (Section F): 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0375545000
• Device Catalogue Number: 0375-545-000
• Device Lot Number: 22052CE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Race: White
• Date Report Sent to FDA: 08/12/2022