MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-16 for APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT manufactured by Synthes Usa.
[92288253]
Patient id and date of birth/age was not provided for reporting. The thread of blade was damaged during the implant procedure on an unknown date in (b)(6) 2016. Patient serious injury due to additional intervention occurred on (b)(6) 2017. This report is for one (1) unknown pfna blade (head element). Part#, lot# and udi # is not available. Date of implant and therapy date is an unknown date in (b)(6) 2016. Device is not expected to be returned for manufacturer review/investigation. This report is for one (1) unknown pfna blade (head element). Pma/510(k) number is not available. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. 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
[92288254]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on an unknown date in (b)(6) 2016, patient was implanted with the nail and the blade. During the procedure, the surgeon damaged the thread of the blade. On (b)(6) 2017, a surgery was performed to extract the implants. They used the normal extraction set but they could not remove the blade as the thread was damaged, the surgery was prolonged for approximately 60 minutes. They had no special instrument to extract the blade from the nail and therefore, closed the surgery without extracting the implants. A special extraction set was sent with tongs to grip that on the blade. During the second surgery on (b)(6) 2017 they could successfully extract the blade and the nail. Patient outcome was not reported. Concomitant reported parts: extraction screw (part# 03. 010. 411, lot# unknown, quantity 1). This report is for one (1) unknown pfna blade (head element). This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-12655 |
| MDR Report Key | 7038906 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-16 |
| Date of Report | 2017-10-09 |
| Date Mfgr Received | 2017-12-01 |
| Date Added to Maude | 2017-11-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2017-11-16 |
| Operator | PHYSICIAN |
| 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 | 1. Required No Informationntervention | 2017-11-16 |