MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. SURG PAT XRAY 1/2 X 3; PADDIE, COTTONOID

Catalog Number 80-1407

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation a follow up report will be filed.

Event Description

During setup for a posterior spinal fusion case, one of the patties in the packet looked like it had a rust or burn stain on it.No impact on procedure.Another packet was opened.No adverse event.Please be aware due to the time difference between (b)(6) versus the u.S.Complaints that are received on the same day that they are entered appear that the complaint created date occurred before the complaint notified date.This is attributed to a system issue associated with the time difference.On (b)(6) 2015 per affiliate: was there a delay in surgery over 30 minutes? no delay just opened another pack of the same.Was the reported contamination found inside or outside of the sterile barrier? outside the sterile field.

Manufacturer Narrative

Upon completion of the investigation, it was noted that the cottonoid is formed from a rayon material.During processing this rayon material is broken down into small, loose fibers.If the fibers do not break down enough, a small cluster of fibers can result.This in turn creates a thick spot in the pattie.When the string is ultrasonically welded on this spot it absorbs more energy than the rest of the pattie and results in a burn.Since the marking is from burnt rayon material, it would not affect the patient during surgery.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time, this complaint is closed.

• Brand Name: SURG PAT XRAY 1/2 X 3
• Type of Device: PADDIE, COTTONOID
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5274946
• MDR Text Key: 32991559
• Report Number: 1226348-2015-10735
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80-1407
• Device Lot Number: 681607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1