MAUDE Adverse Event Report: SURGICAL SPECIALITIES STRATAFIX; STRATAFIX PDO

Model Number SXPD2B412

Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)

Patient Problems Foreign Body Reaction (1868); Skin Irritation (2076)

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

To date, the complaint device has not been returned to surgical specialties corporation for root cause analysis.The lot number have not been provided which precludes a dhr review from being performed at this time including sterility records.Unfortunately without the lot information we are unable to determine a root cause at this time.Should the device be returned to surgical specialties corporation at some point in the future the issue will be re-opened, the device evaluated and the findings from the evaluation will be documented in the complaint file and a follow-up report will be filed at that time.Pdo ("polidioxanone") material is essentially absorbed between 182 and 238 days post implantation.However, this specific material has in vivo strength retention for up to six (6) weeks.All sutures are technically ¿foreign substances¿ that the human body has a tendency to reject.Ideally this means the body breaks them down and dissolves them over a period of 3 or 4 months.Still in some cases, the body decides not to break them down but instead pushes them out through the top of the skin.That is why it is not uncommon for spitting sutures to occur.Spitting of suture material can also be the result of placing the material too superficially.The suture size, type, depth, and technique utilized for each specific procedure can be an important factor in determining an exact root cause for this type of event.Without receiving detailed information regarding the procedure, technique and post-operative details, a definitive root cause cannot be determined at this time.

Event Description

It was reported by the distributor/sales rep that a patient presented with skin irritations and suture spitting.An email was received by the distributor that a skin graft may be required to repair infected or damaged tissue; however, to date no additional information has been forthcoming regarding whether surgical intervention was performed.Pdo ("polidioxanone") material is essentially absorbed between 182 and 238 days post implantation.However, this specific material has in vivo strength retention for up to six (6) weeks.All sutures are technically ¿foreign substances¿ that the human body has a tendency to reject.Ideally this means the body breaks them down and dissolves them over a period of 3 or 4 months.Still in some cases, the body decides not to break them down but instead pushes them out through the top of the skin.That is why it is not uncommon for spitting sutures to occur.Spitting of suture material can also be the result of placing the material too superficially.The suture size, type, depth, and technique utilized for each specific procedure can be an important factor in determining an exact root cause for this type of event.Without receiving detailed information regarding the procedure, technique and post-operative details, a definitive root cause cannot be determined at this time.

• Brand Name: STRATAFIX
• Type of Device: STRATAFIX PDO
• Manufacturer (Section D): SURGICAL SPECIALITIES; rd 459 montana industrial park; aquadilla PR 00605
• Manufacturer (Section G): SURGICAL SPECIALITIES; rd 495 montana industrial pk; aquadilla PR 22235
• Manufacturer Contact: ronald giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 8184790
• MDR Text Key: 131021607
• Report Number: 3010692967-2018-00033
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPD2B412
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2018
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention