MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-10 for PREMIER TIBIAL PUNCH TOWER MOD N/A 32-487269 manufactured by Biomet Orthopedics.
[67384354]
Add'l pro code- hwp. Review of device history records found these units were released to distribution with no deviations or anomalies. Product likely left zimmer biomet conforming. Visual inspection of the product determined that the tower body stem was fractured. The stem appears to have experienced excessive force however, a root could not be determined. This device is used for treatment.
Patient Sequence No: 1, Text Type: N, H10
[67384355]
It was reported that the tibial punch tower fractured during use. The patient did not retain a foreign body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-00583 |
| MDR Report Key | 6321610 |
| Date Received | 2017-02-10 |
| Date of Report | 2017-02-09 |
| Date of Event | 2016-08-15 |
| Date Mfgr Received | 2017-02-07 |
| Device Manufacturer Date | 2008-10-09 |
| 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 | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PREMIER TIBIAL PUNCH TOWER MOD |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | HWP |
| Date Received | 2017-02-10 |
| Returned To Mfg | 2016-10-03 |
| Model Number | N/A |
| Catalog Number | 32-487269 |
| Lot Number | 122780 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-02-10 |