MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-12 for POL TRANS BUTTON LOCK SCREW INSERTER N/A 14-500070 manufactured by Zimmer Biomet Spine.
[57619839]
The returned driver was examined and the tip was found to have been broken off, and not stripped as originally reported. There were no indications of manufacturing issues which would have contributed to this event. The device labeling was reviewed and found to contain instructions on the proper usage of the device.
Patient Sequence No: 1, Text Type: N, H10
[57619840]
It was reported that a driver stripped during use. There was no patient harm or surgical delay associated with this event. However, after the returned device was returned to the manufacturer, it was found that the driver tip fractured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004485144-2016-00278 |
| MDR Report Key | 6024555 |
| Date Received | 2016-10-12 |
| Date of Report | 2016-03-10 |
| Date of Event | 2016-03-02 |
| Date Mfgr Received | 2016-09-19 |
| Device Manufacturer Date | 2015-02-11 |
| Date Added to Maude | 2016-10-12 |
| 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 | MRS. TERESA GEORGE |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | ZIMMER BIOMET SPINE |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POL TRANS BUTTON LOCK SCREW INSERTER |
| Generic Name | SCREWDRIVER |
| Product Code | HWD |
| Date Received | 2016-10-12 |
| Returned To Mfg | 2016-04-15 |
| Model Number | N/A |
| Catalog Number | 14-500070 |
| Lot Number | PW11B |
| 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 | ZIMMER BIOMET SPINE |
| Manufacturer Address | 310 INTERLOCKEN PARKWAY SUITE 120 BROOMFIELD CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-12 |