MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON POLSORB 2/0 30 VIO CV-25 216T

Model Number GL183

Device Problems Break (1069); Component Falling (1105); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Ankle joint fracture: at subcutan suture the needle tip broke off, at 5 foil this happen.Needle tips were searched with x-ray, but could not be found.Surgery time was extended more than 30 due to searching.Risk of stitch injury.No blood loss, no extension of incision, no change of op, no damage or loss of tissue.Additional information received via email 1.The reported lot ae1182 does not look correct.Can you confirm if this is the right lot number? i have changed it to "unknown" in the meantime.The reported lot is a4e1182x.

Manufacturer Narrative

(b)(4).Initial report sent to fda on (b)(4) 2014.

Manufacturer Narrative

(b)(4).

• Brand Name: POLSORB 2/0 30 VIO CV-25 216T
• Type of Device: POLSORB 2/0
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06743 ; 2034925267
• MDR Report Key: 4356463
• MDR Text Key: 5221962
• Report Number: 1219930-2014-01196
• Device Sequence Number: 0
• Product Code: GAM
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GL183
• Device Catalogue Number: GL183
• Device Lot Number: A4E1182X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other