MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2014-05-28 for ROTATING BACKBITER, PED. 1/EA 3712013 manufactured by Medtronic Xomed Inc..
[18302109]
The customer reported that near the tip of the instrument, a piece is snapped off. The instrument was found on an instrument tray during surgery on (b)(6) 2014. There was no injury or impact to the patient reported. The customer was not aware of any fragment of the instrument having to be removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
[18434834]
(b)(4). The device has not been returned. An evaluation/analysis of the devices cannot be performed at this time.
Patient Sequence No: 1, Text Type: N, H10
[33519108]
The instrument was received in an unlabeled padded foam medtronic instrument box. The shaft of the instrument was found bent which was indicative of aggressive use of the instrument by the customer. The instrument was found fractured near the tip which caused the backbiter to not function upon actuation of handle. Upon observing the fractured location, there was some amount of corrosion observed which may have likely deteriorated the material and when compounded with excessive force by the customer during use, the instrument fractured at this location. There was no evidence of improper manufacturing, therefore manufacturing has been ruled out as a potential cause. Based on the above observations; the most likely underlying cause is consistent with mishandling, based on the bent shaft which indicated aggressive use of the instrument and the fractured point. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[101914815]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2014-00123 |
| MDR Report Key | 3836060 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2014-05-28 |
| Date of Report | 2014-05-07 |
| Date of Event | 2014-05-07 |
| Date Mfgr Received | 2014-06-27 |
| Date Added to Maude | 2014-06-30 |
| 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 | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| 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 | ROTATING BACKBITER, PED. 1/EA |
| Generic Name | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2014-05-28 |
| Returned To Mfg | 2014-06-16 |
| Model Number | 3712013 |
| Catalog Number | 3712013 |
| 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 XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-28 |