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 2016-11-21 for 14.0MM CANNULATED AWL 03.010.041 manufactured by Synthes Usa.
[60433238]
(b)(4). Device is an instrument and is not implanted / explanted. Device is not expected to be returned for manufacturer review/investigation. (b)(6). 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 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
[60433239]
Device report from synthes europe reports an event in (b)(6) as follow: it was reported that on (b)(6) 2016, patient underwent surgery for the left sub-trochanteric fracture nonunion. During the surgery, entry point was made to use the ria-system. At the end of the procedure it was detected that the punch (cannulated awl) is broken at the tip. There was no patient harm and all broken off fragments were removed from the patient. The procedure was completed successfully. No information regarding delay in surgery was reported. This report is for one (1) cannulated awl. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2016-15450 |
| MDR Report Key | 6116347 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-21 |
| Date of Report | 2016-10-30 |
| Date of Event | 2016-10-29 |
| Date Mfgr Received | 2016-10-30 |
| Date Added to Maude | 2016-11-21 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK VORNHEDER |
| 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 |
| Brand Name | 14.0MM CANNULATED AWL |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2016-11-21 |
| Catalog Number | 03.010.041 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2016-11-21 |