MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-01-25 for STRATAFIX SXPD2B405 manufactured by Surgical Specialties Corporation Mexico.
[134142204]
The sample devices from lot aacm233 were returned referencing the above complaint. Once the specific lot was identified a thorough review of the device history records was performed and a visual review, and testing was performed on the sterile samples. Additional information was requested; however, very little details were provided explaining the procedure, post-operative compliance or if any intervention was required. A review of the device history records for the reported finished good lot and raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes. There were no other complaints received for this specific finished good lot. Samples from the reported lot were received, visually reviewed, measured for barb placement and depth by our quality team. No visual defects were observed and the barbs meet all current requirements according the current product design for item sxpd2b405. Without receiving pertinent details regarding the pre-operative preparation of the device, surgeon's technique, patient? S pre-existing health conditions/allergies, post-operative instructions or events that may have occurred and/or contributed to the reported event, a definitive root cause cannot be determined at this time. Capa [(b)(4)] was initiated to review the barbing process and address the reported failure of [not barbed/ shallow barbs; barbs not prominent on the device]. Based on the investigation and information collected and analyzed, there are multiple related conditions that could contribute to the reported failure. The following are possible root causes that have been identified throughout the barbing process. Re-training on procedure (b)(4). During the investigation, it was determined that the operators require a greater knowledge of the procedure and setup of the machines. There is a variation in the diameter of the suture between supplier lots. Some areas on the length of the suture can measure closer to the minimum requirement. When this thinner suture is being processed and the machine is set to cut the barbs, the barbs are not cut as deep as the barbs on a thicker, more robust piece of suture material. This can potentially occur within the same lot or box of product and results in variances in how the barbs appear from piece to piece. The suture is often loose on the spool and this requires the machine to be adjusted. The blade loses its edge after several cuts during the process. Worn blades on the barbing machine have an effect on how the barbs are cut on the suture material. The operator can install the wrong? Anvil? During the initial machine setup. The position and setup of the blade will cause a variation of the suture cut. As part of the process review and the investigation the following improvements "has" been implemented or will be implemented to the barbing process and are continuously reviewed and improved: a? Continuous improvement? Certification program was created for all barbing machine operators so they are well trained on the process and the barbing operation [completed on 08/30/2018]. A form (b)(4) was updated by quality to ensure the correct setup on the barbing machine [completed on 09/13/2018]. A pokayoke was installed on all the blade bases of the barbing machine, to avoid variation during the blade set up installation changes [completed on 08/31/2018]. The procedure (b)(4), revision 4 from (b)(4) facility was updated to include all the data from the (b)(4), revision 16 from (b)(4) [completed on 06/29/2018]. The expiration date of the ig charts (reference document for angle and depth measurement of barbs) was changed to every six (6) months [completed on 10/02/2018]. The ig chart (reference document for angle and depth measurement of barbs) will be revised to be? User friendly? For the operator/inspectors [completed on 10/26/18]. A new visual aid (b)(4) was created to measure depth and angle of the barbs. All operators involved in the process have been trained by our engineers [completed on 10/02/2018]. The engineering team updated the procedure (b)(4) to set the frequency to change the blades at least once per week [completed on 10/02/2018]. An engineering study was made to calculate the life of the blade edge [ completed on 10/31/2018].
Patient Sequence No: 1, Text Type: N, H10
[134142205]
It was reported 9 days after knee tep surgery the barbs of the suture did not grip and the fascia layer of the tissue was open. No additional details were disclosed about the procedure, compliance to post-op instructions or the type of intervention that was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010692967-2019-00002 |
| MDR Report Key | 8278926 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-01-25 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-09-09 |
| Date Facility Aware | 2018-09-09 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2018-09-09 |
| Date Mfgr Received | 2018-09-09 |
| Date Added to Maude | 2019-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RONALD GIANNANGELO |
| Manufacturer Street | 247 STATION DRIVE SUITE NE1 |
| Manufacturer City | WESTWOOD MA 02090 |
| Manufacturer Country | US |
| Manufacturer Postal | 02090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATAFIX |
| Generic Name | STRAFIX SUTURE PDO |
| Product Code | GAB |
| Date Received | 2019-01-25 |
| Returned To Mfg | 2018-11-16 |
| Model Number | SXPD2B405 |
| Lot Number | AACM233 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES CORPORATION MEXICO |
| Manufacturer Address | CORREDOR TIJUANA ROSARITO 2000 #24702 B, EJIDO FRANCISCO VILL TIJUANA 22235 MX 22235 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-25 |