MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. FORMULA; STRYKER (ARTHROSCOPIC) FORMULA AGGRESSIVE PLUS CUTTER 4MM

Model Number N/A

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2019

Event Type  malfunction  

Event Description

During the patients surgery the 4 mm aggressive plus shaver broke inside the patients shoulder.The device was removed and the broken piece was retrieved.All pieces saved.New shaved obtained.No mention of event in surgeon's procedural notes except that "frayed portions of affected structures were shaved using a 4 mm synovial shaver.".

• Brand Name: FORMULA
• Type of Device: STRYKER (ARTHROSCOPIC) FORMULA AGGRESSIVE PLUS CUTTER 4MM
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 8590760
• MDR Text Key: 144415860
• Report Number: 8590760
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885825014247
• UDI-Public: (01)00885825014247(17)211206(10)9441087
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 375-544-000
• Device Lot Number: 9441087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA