MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-08-21 for BIPASS PLASTIC NITINOL DISP X1 N/A 902093 manufactured by Biomet Orthopedics.
[11220264]
Evaluation of device found evidence that the device most likely malfunctioned due to user error. This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2013-03327-1 / 03328-1).
Patient Sequence No: 1, Text Type: N, H10
[15198294]
It was reported patient underwent a rotator cuff repair on (b)(4) 2013. During the procedure, when the surgeon passed the suture through the cuff with the first bypass, the tip fractured off and fell in the patient. A second bypass was used and the tip fractured off and fell into the patient both fractured tips were retrieved. As a result, a third bypass was utilized to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[15786967]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2013-03327 / 03328).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2013-03328 |
| MDR Report Key | 3301032 |
| Report Source | 07 |
| Date Received | 2013-08-21 |
| Date of Report | 2013-07-25 |
| Date of Event | 2013-07-19 |
| Date Mfgr Received | 2013-07-25 |
| Device Manufacturer Date | 2012-08-17 |
| Date Added to Maude | 2013-08-21 |
| 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 | MS. ANGIE DICKSON |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIPASS PLASTIC NITINOL DISP X1 |
| Generic Name | PUSHER, SOCKET |
| Product Code | HXO |
| Date Received | 2013-08-21 |
| Returned To Mfg | 2013-08-22 |
| Model Number | N/A |
| Catalog Number | 902093 |
| Lot Number | 955310 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-08-21 |