MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-01-06 for SHAFT FOR TREPHINE ATTACHMENTS 03.111.030 manufactured by Synthes Hagendorf.
[64067583]
Potential patient involvement. Device found broken at sterile processing department. Unknown when the device broke. Patient weight is unknown. Date of event, when the device broke is unknown. Device is an instrument and is not implanted / explanted. The device was received and the product evaluation is in progress. No conclusion can be drawn. Review of device history record 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
[64067585]
It was reported that an open reduction internal fixation was performed on (b)(6) 2016 to repair ankle fracture. Procedure was completed successfully without delay and patient was reported as stable. The shaft for trephine attachments was found broken into two pieces at sterile processing department. It is unknown when the device broke. This report is for one (1) shaft for trephine attachments. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[64461866]
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
[68477776]
Device history records review was conducted. The report indicates that the: this dhr review is for part number 03. 111. 030, lot # 2550855; manufacturing location: (b)(4); manufacturing date: 08. Jun. 2010. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. An investigation summary was performed. The investigation of the complaint articles has shown that:the distal tip of the shaft for trephine attachments has a broken prong. The broken prong was not returned. The remaining two prongs are intact but bent inward. The balance of the device is in good condition. It was reported that the shaft for trephine attachments was found broken into two pieces at sterile processing department. It is unknown when the device was broken. A visual inspection, drawing review and dhr review were performed as part of this investigation. The complaint is confirmed. Replication of the complaint condition is not applicable as the device is already broken. Synthes manufacturing location was discovered upon receipt of subject device. 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 | 2520274-2017-10066 |
| MDR Report Key | 6229509 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-06 |
| Date of Report | 2016-12-15 |
| Date Mfgr Received | 2017-01-19 |
| Device Manufacturer Date | 2010-06-08 |
| Date Added to Maude | 2017-01-06 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES HAGENDORF |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAGENDORF CH4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHAFT FOR TREPHINE ATTACHMENTS |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2017-01-06 |
| Returned To Mfg | 2017-01-05 |
| Catalog Number | 03.111.030 |
| Lot Number | 25550855 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES HAGENDORF |
| Manufacturer Address | IM BIFANG 6 HAGENDORF PA CH4614 SZ CH4614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-06 |