MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-06-09 for PICK, HEAVY SHAFT 3722067 manufactured by Xomed Microfrance Mfg.
[4619437]
Upon receiving a 1. 5mm pt 90 degree pick, it was reported the? Tip was bent? When the package was opened. However, analysis confirmed the tip was broken and not bent. There was no patient impact or injury reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12119491]
(b)(4) - break; material fragmentation. In response to medtronic? S request for device return, the device was received by medtronic? S us manufacturing site for evaluation (detailed as follows): one device was received, product number 3722067 from lot 130701. Analysis found no evidence of biological contaminants and no signs of use... However, a portion of the tip measuring approximately 1. 5mm in length was broke off and was not in the package or in the tip protector. The break point showed deformation consistent with the right angled tip bent in a distal direction before the breakage. There was no evidence of improper manufacturing and there was no significant damage to the packaging to indicate shipping damage... Therefore manufacturing has been ruled as a potential cause, however based off of the size of the tip damage this does not necessarily rule out shipping and handling. The information most likely indicates the tip was bent and broke during the removal of the tip protector which is evident by the scrape proceeding toward the end on the inside diameter where the tip would have been, which is not likely to have occurred unless the tip was still attached and facing outward as shown on the product assembly drawing. Based on the observations; the most likely underlying cause is consistent with, mishandling. Result: stress problem; fracture problem. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00048 |
| MDR Report Key | 3857160 |
| Report Source | 06,07 |
| Date Received | 2014-06-09 |
| Date of Report | 2014-05-15 |
| Date of Event | 2014-05-07 |
| Date Mfgr Received | 2014-05-15 |
| Device Manufacturer Date | 2013-07-12 |
| Date Added to Maude | 2014-07-08 |
| 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 | 0 |
| Manufacturer Contact | JACKLYN HAYMAN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042812769 |
| 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, HEAVY SHAFT |
| Generic Name | PICK, MICROSURGICAL EAR |
| Product Code | JYT |
| Date Received | 2014-06-09 |
| Returned To Mfg | 2014-05-14 |
| Model Number | 3722067 |
| Catalog Number | 3722067 |
| Lot Number | 130701 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOMED MICROFRANCE MFG |
| Manufacturer Address | SAINT-AUBIN-LE-MONIAL BOURBON-L'ARCHAMBAULT 3160 FR 3160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-09 |