MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERNAL SAW II BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS

Model Number 5590

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2017

Event Type  malfunction  

Event Description

It was reported that during the use of the device for a non-clinical activity, the blade protector on the sternal saw was damaged.There was no patient involvement.

Manufacturer Narrative

Updated blocks: the reported complaint was confirmed.The technician from the manufacturer's subsidiary replaced the blade protector resolving the issue.There will be no parts returned to the manufacturer for evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: STERNAL SAW II BLADE
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 7951340
• MDR Text Key: 123259214
• Report Number: 1828100-2018-00532
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• PMA/PMN Number: K935391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5590
• Device Catalogue Number: 5590
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1