MAUDE Adverse Event Report: CARDINAL HEALTH 247, INC F/K/A EMERGE MEDICAL, INC BLADE, SAW, SAGITTAL, 25 X 90 X 1.19, ST; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number C25-119-90

Device Problem Compatibility Problem (2960)

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

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

Cardinal health is filing as the importer of record.The sample was discarded by the customer.The complaint was forwarded to the supplier/manufacturer for investigation, and although any conclusions are difficult to draw at this point, they report that it seems reasonable to assume that the sawblade and the cutting guide and/or implant were not compatible in terms of dimensions.

Event Description

Sagittal sawblades used on a total knee arthroplasty wore faster than usual, appeared "burnt", and caused the stryker power drill to heat up to the point where the surgeon had to delay the case.On (b)(6) 2016 it was learned that the case was delayed an extra hour and a half causing additional exposure time to general anesthesia and possible increased risk of infection to the patient.Customer did not provide any additional information about the patient.

• Brand Name: BLADE, SAW, SAGITTAL, 25 X 90 X 1.19, ST
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 247, INC F/K/A EMERGE MEDICAL, INC; 720 s colorado blvd ste 550s; denver CO 80246
• Manufacturer (Section G): CARDINAL HEALTH 247, INC F/K/A EMERGE MEDICAL, INC; 720 s colorado blvd ste 550s; denver CO 80246
• Manufacturer Contact: michele donatich ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6038530
• MDR Text Key: 57917874
• Report Number: 1423537-2016-00051
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: C25-119-90
• Device Lot Number: 160614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/20/2016
• Date Manufacturer Received: 09/20/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other