MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2012-12-28 for RHOTON HOOK ANG 90DEG SEMI-SHARP 7-1/2IN NL3785-009 manufactured by Carefusion.
[3062002]
Broken information received from medwatch form (b)(4):? During procedure, the tip of the micro gray carefusion v. Mueller nerve hook broke off during use.? The missing portion was estimated at about 1mm in length.? The surgeon searched the wound and an intraoperative x-ray was taken.? The x-ray was read as negative for foreign body identified.? The nerve hook was taken out of use.? Additional information obtained on (b)(6)2012 after speaking with the customer (risk manager).? The instrument number and lot number were provided.? The instrument cannot be returned to carefusion.? However, a carefusion representative may visit the site to see the instrument if an agreement is signed.? In addition, pictures of the instrument will be provided once the agreement has been signed.
Patient Sequence No: 1, Text Type: D, B5
[10384342]
(b)(4), customer is not willing to send device to carefusion for evaluation. They might be willing to send photo's. If photos are made available, we will do an evaluation based on the photo's and a follow up will be sent.
Patient Sequence No: 1, Text Type: N, H10
[10578340]
(b)(4): no instrument or pictures were supplied to aid the investigation. The product and lot code were reported as being (b)(4) manufactured in february 2007. This would mean the instrument was over 5 years old. The information supplied from the user, is that approximately 1mm of the tip broke off, it is unknown if the 1mm was from the overall length or only the tip (the tip of the instrument noted is approximately 2mm after a 90 degree bend). The condition of the instrument prior to the incident reported is unknown. It is also unknown if the instrument had been modified prior to this incident. In the past year, there have been no rejections or deviations related to the instrument breaking during the manufacture of this product. This is the only complaint on record for this product code in more than 5 years.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1923569-2012-00023 |
| MDR Report Key | 2889595 |
| Report Source | * |
| Date Received | 2012-12-28 |
| Date of Report | 2012-12-03 |
| Date of Event | 2012-11-16 |
| Date Mfgr Received | 2012-12-03 |
| Date Added to Maude | 2012-12-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | CAREFUSION 2200 INC (ST. LOUIS) |
| Manufacturer Street | 5 SUNNEN DR |
| Manufacturer City | ST. LOUIS MO 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 ANG 90DEG SEMI-SHARP 7-1/2IN |
| Generic Name | INSTRUMENT, MICROSURGICAL |
| Product Code | GZX |
| Date Received | 2012-12-28 |
| Model Number | NL3785-009 |
| Lot Number | B07 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-28 |