MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-03-29 for BIPASS DISPOSABLE NITINOL SINGLE PACK N/A 902092 manufactured by Biomet Sports Medicine.
[1338528]
It was reported that patient underwent a procedure utilizing a suture passer on (b)(6) 2010. During the procedure, the nitinol wire fractured inside the passer and would not push the suture. There was no delay to the procedure or injury to the patient as a result.
Patient Sequence No: 1, Text Type: D, B5
[8482499]
Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur. Evaluation of the returned device found that it was undamaged. Functional evaluation of the device in conjunction with the suture passer instrument, it was attempted for use with found that it could not be properly inserted into the suture passer instrument. The suture passer cannulation appeared to be blocked. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2010-00101 |
| MDR Report Key | 1644160 |
| Report Source | 07 |
| Date Received | 2010-03-29 |
| Date of Report | 2010-03-04 |
| Date of Event | 2010-03-04 |
| Date Facility Aware | 2010-03-12 |
| Date Mfgr Received | 2010-03-04 |
| Device Manufacturer Date | 2010-01-29 |
| Date Added to Maude | 2010-10-06 |
| 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 | 3 |
| Manufacturer Contact | MRS. MIRANDA PARCELS |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET SPORTS MEDICINE |
| Manufacturer Street | 56 EAST BELL DRIVE P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIPASS DISPOSABLE NITINOL SINGLE PACK |
| Generic Name | PUSHER |
| Product Code | HXO |
| Date Received | 2010-03-29 |
| Returned To Mfg | 2010-03-09 |
| Model Number | N/A |
| Catalog Number | 902092 |
| Lot Number | 335180 |
| ID Number | N/A |
| Device Expiration Date | 2015-01-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPORTS MEDICINE |
| Manufacturer Address | 56 EAST BELL DRIVE P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-29 |