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

Model Number 15665

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.Per the operating room equipment coordinator, this was discovered during cleaning.

Event Description

It was reported that during the use of the device for non-clinical activity, the user lost a piece of screw the sternal saw flexible drive cable.There was no patient involvement.

Manufacturer Narrative

The service repair technician (srt) observed that a piece of screw in the sternal saw cable was lost.The flex cable was missing tapered nut that encapsulates the core assembly into the outer casing.The technician could not perform functional test to the flex cable and disassembled cable and observed lack of lubrication.The srt installed a new casing assembly.The srt performed verification/release testing.The unit operated according to manufacturer specifications.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: SARNS STERNAL SAW II
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6141286
• MDR Text Key: 61541327
• Report Number: 1828100-2016-00771
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 15665
• Device Catalogue Number: 15665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1