MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-04-12 for BIPASS DISP NITINOL SINGLE N/A 902092 manufactured by Biomet Sports Medicine.
[18499638]
It was reported that patient underwent rotator cuff repair procedure on (b)(6) 2012. During the procedure, the nitinol guide fractured after passing through the rotator cuff tissue. Part of the guide had to be retrieved from the shoulder, and the other part remained stuck in the punch. A delay of ninety minutes occurred before the surgery could be completed.
Patient Sequence No: 1, Text Type: D, B5
[18749268]
The user facility is outside of the united states. No medwatch report was received. 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. This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2012-00450 / 00451).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00451 |
| MDR Report Key | 2533212 |
| Report Source | 01,07 |
| Date Received | 2012-04-12 |
| Date of Report | 2012-03-15 |
| Date of Event | 2012-03-06 |
| Date Mfgr Received | 2012-03-15 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2012-04-13 |
| 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. ANGELA DICKSON |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET SPORTS MEDICINE |
| Manufacturer Street | 56 E. 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 DISP NITINOL SINGLE |
| Generic Name | PUSHER, SOCKET |
| Product Code | HXO |
| Date Received | 2012-04-12 |
| Model Number | N/A |
| Catalog Number | 902092 |
| Lot Number | 859210 |
| ID Number | N/A |
| Device Expiration Date | 2015-07-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPORTS MEDICINE |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-04-12 |