MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-04-11 for PROTHESIS, TOE, HEMI- PHALANGEAL UNIVERSAL HANDLE MHTLGTH manufactured by Tornier Inc..
[72462347]
This is the final report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
[72462348]
It was reported the universal handle would not grip proximal/distal broach to pull out of the bone, causing considerable destruction of the bone as it was forced out, and harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004983210-2017-00014 |
| MDR Report Key | 6482706 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-04-11 |
| Date of Report | 2017-03-13 |
| Date of Event | 2017-03-13 |
| Date Mfgr Received | 2017-03-13 |
| Date Added to Maude | 2017-04-11 |
| 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 | MR. DUSTIN SMITH |
| Manufacturer Street | 10801 NESBIT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9529217121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTHESIS, TOE, HEMI- PHALANGEAL UNIVERSAL HANDLE |
| Generic Name | UNIVERSAL HANDLE |
| Product Code | KWD |
| Date Received | 2017-04-11 |
| Catalog Number | MHTLGTH |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC. |
| Manufacturer Address | 10801 NESBIT AVENUE SOUTH BLOOMINGTON MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-04-11 |