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 2019-04-10 for STRATAFIX SXPD2B400 manufactured by Surgical Specialties Corporation.
[141462342]
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. The needle itself is from supplied by an outside supplier. A review of the device history records for the finished good lot, did not identify any quality issues during the incoming, manufacturing, in-process or final inspection processes. There have been no lots released for distribution which failed to meet any of the product specifications or current acceptance criteria.
Patient Sequence No: 1, Text Type: N, H10
[141462343]
It was reported that needle tip broke during laparoscopic excavation. Searched for the broken piece with a c-arm and flush with saline. It was not found in patient body. Changed another one to complete.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010692967-2019-00012 |
| MDR Report Key | 8499429 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-04-10 |
| Date of Report | 2019-04-10 |
| Date of Event | 2018-12-31 |
| Date Facility Aware | 2018-12-31 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2005-01-14 |
| Device Manufacturer Date | 2017-01-31 |
| Date Added to Maude | 2019-04-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 CORPORATION |
| Manufacturer Street | RD 495 MONTANA INDUSRIAL PARK |
| Manufacturer City | AGUADILLA 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 | STRAFIX PDO |
| Product Code | GAB |
| Date Received | 2019-04-10 |
| Model Number | SXPD2B400 |
| Lot Number | MDVH410 |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES CORPORATION |
| Manufacturer Address | RD. 495 MONTANA INDUSTRIAL PK AGUADILLA PR 00605 US 00605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-10 |