MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-06 for CLOSED KNOT PUSHER N/A 902813 manufactured by Biomet Orthopedics.
[11478932]
Examination of returned device found no evidence of product non-conformances.
Patient Sequence No: 1, Text Type: N, H10
[16593820]
It was reported patient underwent a labral repair procedure on (b)(6) 2013. During the procedure, the knot pusher cut four juggerknot anchors and four other juggerknot anchors disengaged from the bone during setting. Subsequently, surgeon utilized a new knot pusher and switched from a curved disposable instrument kit to a straight instrument kit. As a result, a 60 minute delay occurred and eleven anchors were used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[16714292]
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. Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date. In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results. This report is number 2 of 2 mdr's filed for the same event (reference 1825034-2013-05139 / 05140).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2013-05140 |
| MDR Report Key | 3452237 |
| Report Source | 07 |
| Date Received | 2013-11-06 |
| Date of Report | 2013-10-10 |
| Date of Event | 2013-10-10 |
| Date Mfgr Received | 2013-10-10 |
| Device Manufacturer Date | 2009-11-30 |
| Date Added to Maude | 2014-02-05 |
| 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. AMANDA ZAJICEK |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726782 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| 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 | CLOSED KNOT PUSHER |
| Generic Name | PUSHER, SOCKET |
| Product Code | HXO |
| Date Received | 2013-11-06 |
| Returned To Mfg | 2013-11-14 |
| Model Number | N/A |
| Catalog Number | 902813 |
| Lot Number | 948870 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-11-06 |