MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2013-02-11 for PICK 3722066 1MM PT 90 DEG manufactured by Medtronic, Inc..
[3141250]
It was reported that during a procedure, the pick's tip broke off in the child's ear. The doctor was performing a cochlear implant on the child and saw that the tip broke off. He stated that he saw the suction suck up the tip of the pick. The doctor is fully confident that the tip was sucked up by the suction, and the doctor is not going to do an x-ray. There was no patient impact and there was no delay in surgery. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[10581142]
This device is used for therapeutic purposes. (b)(4). The device was not returned. The device was not returned and therefore no evaluation could be performed.
Patient Sequence No: 1, Text Type: N, H10
[10608300]
The complaint device was returned for analysis. Analysis found that the tip was broken off at the extreme end of the instrument. At this point in the shaft, the diameter of metal is very thin such that a 90 degree bend in the metal can be made by the supplier and leave a 1. 0 mm pick extension. The stress on the metal to produce a 90 degree bend is significant on the 1. 4021 surgical stainless steel material. This unit was manufactured in june 2012, so age of the instrument is not a factor. There were no other units from this manufacturing lot to review. Comparing this unit to the same instrument in lot 201206mf2 showed no differences. Analysis has concluded that the most likely root cause is due to excessive force being applied to the end of the device.
Patient Sequence No: 1, Text Type: N, H10
[17649313]
In a previous mdr, an expiration date was reported. This device does not have an expiration date.
Patient Sequence No: 1, Text Type: N, H10
[102625305]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2013-00002 |
| MDR Report Key | 2954802 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2013-02-11 |
| Date of Report | 2013-01-17 |
| Date of Event | 2013-01-17 |
| Date Mfgr Received | 2013-03-27 |
| Device Manufacturer Date | 2012-06-19 |
| Date Added to Maude | 2013-04-24 |
| 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 | JONATHAN SCHLECH |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328355 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PICK 3722066 1MM PT 90 DEG |
| Generic Name | PICK, MICROSURGICAL EAR |
| Product Code | JYT |
| Date Received | 2013-02-11 |
| Returned To Mfg | 2013-02-18 |
| Model Number | 3722066 |
| Catalog Number | 3722066 |
| Lot Number | 201206MF1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-11 |