MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-01-27 for WIRE, FIXATION, INTRAOSSEOUS manufactured by Synthes Usa.
[17587240]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on the (b)(6) in 2015, during a surgery, the surgeon had tried to insert the multilock screw into the b hole after the temporary fixing by the use of the k wire following the nail insertion and the prior dry check, however, it was unable to lead the screw correctly through the hole. The surgeon eventually brought off the insertion of the screw into the b hole after having inserted all other screws first. There was a 15-minute delay in the surgery but without any harm to the patient. This report is 3 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[17700992]
Device was used for treatment, not diagnosis. This report is for one unknown k wire/unknown lot number. Without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[22221458]
An investigation summary was performed. The investigation of the complaint articles has shown that: no material was returned for investigation, no investigation possible for all article unknown k-wire there was no material available, this investigation is for information only. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2015-10609 |
| MDR Report Key | 4458288 |
| Report Source | 01,05,07 |
| Date Received | 2015-01-27 |
| Date of Report | 2015-01-15 |
| Date of Event | 2015-01-07 |
| Date Mfgr Received | 2015-04-29 |
| Date Added to Maude | 2015-01-27 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | WIRE, FIXATION, INTRAOSSEOUS |
| Product Code | DZK |
| Date Received | 2015-01-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-27 |