MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-01 for QUILL RA-1065Q manufactured by Surgical Specialties Mexico.
[143739117]
The actual devices were not returned for review/testing. Sealed, sterile samples from the reported lot were received for visual review and testing. No defects were observed on any of the devices. The suture was dimensionally measured and reviewed for barb angle, depth and placement on the suture strand. The samples met all current requirements for item ra-1065q. The sutures were tensile tested according to our procedures and met usp requirements for #2 pdo material. The root cause for the suture breaking post-operative is difficult to determine without receiving samples of the actual device(s) to examine under a microscope, magnified photographs of the actual device(s), photos of the dehisced incision(s), details regarding the pre-operative preparation of the device(s), procedure performed, surgeon? S technique, patient specifics (ex. Weight, age, health status (diabetic, obese, poor circulation), post-operative instructions not followed or events that may have occurred that resulted in injury to the incision or suture failing (ex. Fall, strain).
Patient Sequence No: 1, Text Type: N, H10
[143739118]
Two (2) cases of sutures breaking post-operative were reported by the operating facility. Patients returned to have incisions repaired (total knee). No permanent tissue damage or patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010692967-2019-00014 |
| MDR Report Key | 8570404 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-01 |
| Date Facility Aware | 2019-04-04 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2019-04-04 |
| Date Mfgr Received | 2019-04-04 |
| Device Manufacturer Date | 2018-12-26 |
| Date Added to Maude | 2019-05-01 |
| 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 | MS. KELLY KNAPPENBERGER |
| Manufacturer Street | 1100 BERKSHIRE BLVD. STE 308 |
| Manufacturer City | READING PA 19608 |
| Manufacturer Country | US |
| Manufacturer Postal | 19608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUILL |
| Generic Name | QUILL BARBED SUTURE DEVICE |
| Product Code | GAB |
| Date Received | 2019-05-01 |
| Model Number | RA-1065Q |
| Catalog Number | RA-1065Q |
| Lot Number | AADO020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES MEXICO |
| Manufacturer Address | CORREDOR TIJUANA-ROSARITO 2000 EJIDO FRANCISCO VILLA TIJUANA 22235 MX 22235 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-01 |