MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-10 for POWERPUMP DAY CASSETTE 10PK NI 941012 manufactured by Biomet Sports Medicine.
[67397302]
Current information is insufficient to permit a conclusion as to the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[67397303]
During an arthroscopy procedure, the cassette was reported to be leaking fluid. Another cassette was utilized to complete the procedure. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[115112671]
This follow-up report is being submitted to relay additional information. (b)(4). Manufacture date: unknown date, january 2016. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action(s) is/are required. Root cause was determined by supplier investigation to be user related. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-00402 |
| MDR Report Key | 6324208 |
| Date Received | 2017-02-10 |
| Date of Report | 2017-09-11 |
| Date of Event | 2017-01-13 |
| Date Mfgr Received | 2017-09-08 |
| Device Manufacturer Date | 2016-01-31 |
| Date Added to Maude | 2017-02-10 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| 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 | NI |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POWERPUMP DAY CASSETTE 10PK |
| Generic Name | ARTHROSCOPY |
| Product Code | HAX |
| Date Received | 2017-02-10 |
| Model Number | NI |
| Catalog Number | 941012 |
| Lot Number | 16A01 |
| ID Number | SEE H10 NARRATIVE |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-02-10 |