MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-01-11 for STRATAFIX manufactured by Surgical Specialties.
[132794374]
To date the sample has not been received. The lot number has not been provided therefore making a dhr review impossible at this time. Without reviewing the actual sample, an exact root cause for the non-conformance reported cannot be determined at this time. A possible cause could be bending, fracturing, breaking of a needle can occur when needles are gripped with a needle holder/forceps at the swaged area and/or near the tip of the device. The stress at the gripped area may exceed the maximum stress of the material resulting in bending and/or failure (broken needle). The stress on the attachment section is greatly reduced when the needle is held in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point as indicated in the ifu for this product.
Patient Sequence No: 1, Text Type: N, H10
[132794375]
It is being reported by our affiliate the needle broke off underneath the skin. X-rays were used to locate and retrieve the broken piece and there no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010692967-2019-00001 |
| MDR Report Key | 8239711 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-01-11 |
| Date of Report | 2019-01-11 |
| Date of Event | 2018-12-17 |
| Date Facility Aware | 2018-12-17 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2018-12-31 |
| Date Mfgr Received | 2018-12-31 |
| Date Added to Maude | 2019-01-11 |
| 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 |
| Manufacturer G1 | SURGICAL SPECIALTIES |
| Manufacturer Street | RD 495 MONTANA INDUSTRIAL PARK |
| Manufacturer City | AQUADILA PR 00605 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00605 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATAFIX |
| Generic Name | STRATAFIX MONODERM SUTURE |
| Product Code | GAB |
| Date Received | 2019-01-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES |
| Manufacturer Address | RD 495 MONTANA INDUSTRIAL PARK AGUADILA PR 00605 US 00605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-11 |