MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-09 for RHOTON HOOK 90DEG BLUNT OVERLGTH 7-1/2IN NL3785-010 manufactured by Carefusion.
[31075697]
(b)(4): if further information becomes available a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[31075698]
Maude report mw5055958 states "a micro dissector tip broke off inside the surgical site. Doctor was able to locate and remove the broken tip. The tip and the instrument were immediately removed from the sterile field. Additional information received 03nov2015: the customer reported there was no patient injury, broken tip removed. The tip broke off in the patient's body during a c4-c5 laminectomy. The physician was able to remove it. The physician was using the device at the time of the issue. The laminectomy was completed as planned. The device and tip will not be returned for investigation.
Patient Sequence No: 1, Text Type: D, B5
[35754689]
(b)(4): one (1) nl3785-010 rhoton hook 90deg blunt overlgth 7-1/2in was reported as the complaint sample. Per complaint description the sample broke during the surgical procedure and the broken piece fell inside the patient. The broken piece was recovered and no patient injury or harm occurred. Sample was not sent in for evaluation or investigation. Sample was possibly removed or discarded by the end-user. Lot code a10 was reported. Device history records for nl3785-101 from lot code a10 could not be located for review. It is not known if there are any nl3785-101 products manufactured for lot a10. Customer may have reported wrong lot code. Product sample was not sent in for evaluations and investigations. Review of reference processes were normal and were not suspected to contribute to the reported failure mode description. Root cause could not be determined as the sample was not returned. The applicable personnel have been made aware of the complaint description and the reported failure mode. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1923569-2015-00020 |
| MDR Report Key | 5212144 |
| Date Received | 2015-11-09 |
| Date of Report | 2015-11-09 |
| Date of Event | 2015-08-19 |
| Date Mfgr Received | 2016-01-11 |
| Date Added to Maude | 2015-11-09 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION 2200 INC (ST. LOUIS) |
| Manufacturer Street | 5 SUNNEN DR |
| Manufacturer City | ST. LOUIS 63143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHOTON HOOK 90DEG BLUNT OVERLGTH 7-1/2IN |
| Generic Name | INSTRUMENT, MICROSURGICAL |
| Product Code | GZX |
| Date Received | 2015-11-09 |
| Model Number | NL3785-010 |
| Lot Number | A10 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-09 |