MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-05 for WIRE manufactured by Synthes.
[2919384]
Pt underwent surgery on (b)(6) 2012 for? Hardware removal from left patella of two? 4. 0 cannulated screws? Screw heads and wires after receiving surgery of? Open reduction and internal fixation of the left patella? On (b)(6) 2011. The pt reported pain and wished to have hardware removed. During the surgery, the hardware and screw heads were identified and removed w/o difficulty according to the operating report. The wires were cut and pulled also w/o difficulty. Two fluoroscopic images confirmed that the hardware were removed successfully and the pt was discharged w/o complications.
Patient Sequence No: 1, Text Type: D, B5
[10238466]
(b)(4). Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided. Mfg records could not be reviewed w/o a lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-02167 |
| MDR Report Key | 2794181 |
| Report Source | 05,06 |
| Date Received | 2012-10-05 |
| Date of Report | 2012-09-06 |
| Date Facility Aware | 2012-08-15 |
| Report Date | 2012-09-03 |
| Date Reported to Mfgr | 2012-09-03 |
| Date Mfgr Received | 2012-09-06 |
| Date Added to Maude | 2012-10-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JODI TEMPLE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WIRE |
| Generic Name | WIRE |
| Product Code | DZK |
| Date Received | 2012-10-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES |
| Manufacturer Address | WEST CHESTER PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-05 |