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Model Number SXPD2B202
Device Problem Insufficient Information (3190)
Patient Problem Wound Dehiscence (1154)
Event Date 01/29/2018
Event Type  Injury  
Manufacturer Narrative
Method-the actual devices were discarded by the end user. Samples from the reported lot were not returned for testing/review. A sample was retained with the device history record. Results/conclusion-a retained sample from the same lot was reviewed and photographed. The sample was barbed and met all current requirements for this size/type barbed suture device. Relevant portions of the device history record were reviewed. The finished good devices and all components met current usp and ssm requirements throughout the incoming inspection, manufacturing and final inspection processes. No inventory is available of the reported finished good lot. The retained sample was barbed per current requirements. Without receiving detailed information regarding the procedure, suture placement, technique utilized by the surgeon, patient specific health status, post-operative instructions or events a definitive root cause for the reported dehiscence cannot be confirmed at this time.
Event Description
It was reported by the distributor that during a total knee procedure the surgeon noted little to no barbs on four (4) (b)(4) devices. The devices were utilized and the fascia layer was closed without incident. However, later (post-operatively) the surgeon learned of wound dehiscence. No additional details regarding the patient's health status or other patient specific information was obtained. Detailed information regarding the surgeon's technique, post-operative events that may have induced the dehiscence or type of medical intervention provided were not disclosed.
Manufacturer Narrative
Four (4) unopened samples and one (1) opened sample of item (b)(4) from finished good lot aabr631 were received at the (b)(4). A visual inspection was performed on the opened sample. Barbs were observed on the device, however they appeared shallow. A dimensional inspection was performed on the unopened samples. All of the devices measured below the acceptance criteria. The same samples were sent to the manufacturing site in (b)(4). The devices were measured and the barb depth measurements were also confirmed below the acceptance value specified for this size suture. The root cause for the barbs measuring below the specified criteria is attributable to the barb cutting process. In-process inspection/measurements are currently performed every thirty (30) units to assure adequate barb depth. A corrective /preventive action, (b)(4) was initiated at the tijuana facility.
Manufacturer Narrative
On 2/19/18, four (4) unopened samples and one (1) open sample of item sxpd2b202 from finished good lot aabr631 were received at the (b)(4) facility premises. A visual inspection was performed of the open sample and it had barbs, however they were shallow. A dimensional inspection was performed on the unopened samples and all of them were found outside the acceptance criteria. All samples were sent to the (b)(4) facility on 3/13/18. Samples were measured at (b)(4) and found below specification. The root cause for shallow barbs was identified as the method used in measuring the samples. A corrective /preventive action, capa (b)(4) was opened at the (b)(4) facility to address the issue. This complaint shall be included in the trend analysis. We will continue to closely monitor for experiences of this type.
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Type of DeviceSTRATAFIX SXPD2B202 20S-8 #2 PDO 36 X 36
Manufacturer (Section D)
corredor tijuana rosarito 2000
24702-b, ejido francisco villa
tijuana 22235
MX 22235
MDR Report Key7280431
MDR Text Key100412029
Report Number3010692967-2018-00002
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2017
Device Model NumberSXPD2B202
Device Catalogue NumberSXPD2B202
Device Lot NumberAABR631
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/18/2018
Device Age6 MO
Event Location Hospital
Date Manufacturer Received01/29/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/19/2018 Patient Sequence Number: 1