MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-05 for HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE 399.68 manufactured by Synthes Usa.
[27859618]
No patient involvement. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[27859619]
It was reported that the gouge "flaked off" during the cleaning process. No patient involvement. There is no additional information at this time. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[31043731]
Device was used for treatment, not diagnosis. A service history record review was attempted for the subject device. The review could not be completed because the device is a lot-controlled item. The date of manufacture is unknown. The service history evaluation is unconfirmed. A service and repair evaluation was performed for the subject device. The customer reported the gouge flaked off during a procedure. The repair technician reported the handle was cracked. ? Handle cracked/broken? Is the reason for repair. The item is not repairable. The cause of the issue is unknown. This item was forwarded to the synthes complaint handling unit on 23-oct-2015 for additional investigation. The service and repair evaluation was confirmed. A product development investigation was performed for the subject device by the synths complaint handling unity. One hollow gouge for broken screw exposure (part number: 399. 68, lot number: 2036). The gouge is part of the screw removal set for removing synthes screws. The gouge is used to remove the bone surrounding the screw shaft prior to screw removal per the technique guide. Upon visual inspection of the complaint device the complaint description has been confirmed, there is noticeable flaking of the handle towards the distal end of the instrument. The balance of the device is in good condition with minor wear and tear consistent with use. The associated drawing for the subject device was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended. A root cause could not be determined, most likely the instrument has been in the field for several years and went through multiple uses and sterilization cycles causing the complaint condition. 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
[31056179]
Subject device has been received and is currently in the evaluation process. A review of the service history records has been requested. 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 | 2520274-2015-16448 |
| MDR Report Key | 5128462 |
| Date Received | 2015-10-05 |
| Date of Report | 2015-09-23 |
| Date Mfgr Received | 2015-10-26 |
| Date Added to Maude | 2015-10-05 |
| 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 | LINDA PLEWS |
| 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 | HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE |
| Generic Name | GOUGE,SURGICAL,GEN & PLASTIC SURGERY |
| Product Code | GDH |
| Date Received | 2015-10-05 |
| Returned To Mfg | 2015-10-08 |
| Catalog Number | 399.68 |
| Lot Number | 2036 |
| Operator | SERVICE AND TESTING PERSONNEL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-10-05 |