MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-26 for BIPASS DISPOSABLE NITINOL PUSH ER SINGLE N/A 902092 manufactured by Biomet Sports Medicine.
[55938010]
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. The following sections could not be completed with the limited information provided. Date of event? Ni. Initial reporter? Surgeon - ni. Manufacture date? Ni. This report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2016-03803 / 03804).
Patient Sequence No: 1, Text Type: N, H10
[55938011]
It was reported that there was significant resistance/friction of the nitinol needle passing through the suture punch. There was no patient injury or delay in procedure. A competitor product was used to complete this procedure.
Patient Sequence No: 1, Text Type: D, B5
[69171163]
This follow-up report is being filed to relay this report is a duplicate of 1825034-2016-02271.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2016-03804 |
| MDR Report Key | 5978065 |
| Date Received | 2016-09-26 |
| Date of Report | 2016-08-08 |
| Date of Event | 2016-05-26 |
| Date Mfgr Received | 2017-02-03 |
| Date Added to Maude | 2016-09-26 |
| 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 | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| 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 | BIPASS DISPOSABLE NITINOL PUSH ER SINGLE |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | HXO |
| Date Received | 2016-09-26 |
| Model Number | N/A |
| Catalog Number | 902092 |
| Lot Number | NI |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-09-26 |