MAUDE Adverse Event Report: STRYKER CORPORATION PRECISION THIN; BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL

Model Number 2296003111

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 12/20/2018

Event Type  malfunction  

Event Description

The saw blade broke in half during an acl.

• Brand Name: PRECISION THIN
• Type of Device: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 8280940
• MDR Text Key: 134210003
• Report Number: 8280940
• Device Sequence Number: 1
• Product Code: GFA
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2296003111
• Device Catalogue Number: 2296003111
• Device Lot Number: 18295037
• 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: 12/21/2018
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6935 DA