MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-26 for NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.260 STERILE 216704 manufactured by Aspen Surgical Products, Caledonia.
[129322966]
Aspen surgical received a report from the end user indicating that a circle taper point needle broke during a procedure. The actual device was not available for evaluation. No photo was provided for review. Manufacturing lot number was available. The end user indicated that during a right open hamstring repair the needle tip broke. The surgeon completed the surgery and xrays were not performed. The broken piece was not recovered or found. The customer indicated the needle tip may not be in the patient, and the surgeon did not pursue any attempts to locate the needle tip if inside the patient. There was no injury alleged or prolonged procedure to retrieve. The dhr and analysis results were reviewed. All samples passed acceptance criteria. No non-conformance's were noted related to the reported issue. According to aspen surgical's ifu, the needles should not be clamped directly on the eye of the needle to the point and should be applied to the flat portion of the needle about 1/4 of the needle length from the eye end to prevent needle breaks. Based on this information, due to no picture or sample being available to aid with the complaint investigation, no further action is required. The cause could not be established for needle breakage.
Patient Sequence No: 1, Text Type: N, H10
[129322967]
Aspen surgical received a report from the end user indicating that a circle taper point needle broke during a procedure. This report was filed in our complaint handling system as complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2018-00122 |
| MDR Report Key | 8103256 |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-11-01 |
| Device Manufacturer Date | 2018-02-26 |
| Date Added to Maude | 2018-11-26 |
| 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. JORDAN HACKERT |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6165367508 |
| Manufacturer G1 | SAME AS ABOVE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.260 STERILE |
| Generic Name | SURGICAL NEEDLE |
| Product Code | GAB |
| Date Received | 2018-11-26 |
| Model Number | 216704 |
| Lot Number | 150260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-26 |