MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-06-25 for VARIOUS NEEDLEHOLDERS AND ONE FORCEP manufactured by Aesculap Ag & Co. Kg.
[6073136]
During an orthopedic procedure on (b)(6) 2015, it was noticed that a set of instruments were extremely stained / rusted. There were concerns of sterility and the complete set up was taken down which delayed the surgical procedure by 60 to 90 minutes. No patient injury. Items to be returned: bm066r x 1 : tc mayo-hegar ndl holderhvyserr185mm, bm019r x 2 : tc crile-wood ndl hldrstd serr 200mm, bm016r x 1 : tc crile-wood ndl hldrstrserr 145mm, bm012r x 1 : tc halsey needle holder serr 130mm, bh111r x 2 : halsted-mosquito forceps del cvd125mm.
Patient Sequence No: 1, Text Type: D, B5
[14223018]
Manufacturing site evaluation: evaluation on going.
Patient Sequence No: 1, Text Type: N, H10
[35325668]
(b)(4). Devices received for evaluation include: bm066r x 1 manufacturing code -7573p; manufacture date is 2005. Heavy rust colored staining at the distal tip. Shows signs of prior repair. Bm019r x 2: manufacturing code -at0al; manufacture date is 2008. Heavy rust colored staining at the distal tip. Shows signs of prior repair. Manufacturing code -g5098; manufacture date is 2014. Moderate rust colored staining at the distal tip. No signs of prior repair (tape marks). Bm016r x 1 manufacturing code - g5547; manufacture date is 2014. Moderate rust colored staining at the distal tip. No signs of prior repair (tape marks). Bm012r x 1 manufacturing code - g53k6; manufacture date is 2014. Heavy rust colored staining at the distal tip. No signs of prior repair (tape marks). Bh111r x 2: manufacturing code -ewipd; manufacture date is 2012. Moderate rust colored staining in the box lock. No signs of prior repair (tape marks). Manufacturing code -gvuex; manufacture date is 2014. Heavy rust colored staining in the box locl. No signs of prior repair (tape marks). Evaluation of the devices indicates no improper repair or material or manufacturing defects present. Staining can be attributed to improper care and handling due to inadequate water quality and / or cross contamination of metals. No corrective / preventive action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00545 |
| MDR Report Key | 4890780 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-06-25 |
| Date of Report | 2015-12-31 |
| Date of Event | 2015-05-20 |
| Date Mfgr Received | 2015-05-27 |
| Date Added to Maude | 2015-07-07 |
| 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. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG&CO KG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARIOUS NEEDLEHOLDERS AND ONE FORCEP |
| Generic Name | NEEDLE HOLDERS, HXK / HTD |
| Product Code | HXK |
| Date Received | 2015-06-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN, DE 78532 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-25 |