MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-05 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE MB47G manufactured by Ethicon, Inc..
[18525336]
It was reported that a patient underwent a right shoulder hemiarthroplasty on (b)(6) 2012 and suture was used. While passing the suture through the biceps groove out anteriorly into the lesser tuberosity, the needle tip broke. A xray was done to locate the fragment. However, the needle fragment was embedded in the bone and not removed. There are no plans to remove the needle fragment.
Patient Sequence No: 1, Text Type: D, B5
[18760294]
(b)(4): no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. This medwatch report is in response to receipt of medwatch (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2012-07823 |
| MDR Report Key | 2858069 |
| Report Source | 05,06 |
| Date Received | 2012-12-05 |
| Date of Report | 2012-11-13 |
| Date of Event | 2012-09-04 |
| Date Facility Aware | 2012-09-04 |
| Report Date | 2012-11-13 |
| Date Reported to Mfgr | 2012-11-13 |
| Date Mfgr Received | 2012-11-13 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2012-12-05 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL LAMONT |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082182708 |
| Manufacturer G1 | ETHICON, INC. SAN LORENZO |
| Manufacturer Street | ROAD 183, KM. 8.3 INDUSTRIAL AREA |
| Manufacturer City | HATO PR 00754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE |
| Generic Name | SUTURE, NON-ABSORBABLE |
| Product Code | GAS |
| Date Received | 2012-12-05 |
| Model Number | NA |
| Catalog Number | MB47G |
| Lot Number | EBR323 |
| ID Number | NA |
| Device Expiration Date | 2017-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-05 |