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 2017-10-27 for SHAFT FOR TREPHINE ATTACHMENTS 03.111.030 manufactured by Synthes Bettlach.
[91096165]
Device used for treatment, not diagnosis. Patient age, dob & weight not provided for reporting. Device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Device history records review was conducted. The report indicates that the: part 03. 111. 030 / lot 9481881. Manufacturing location: (b)(4). Manufacturing date: 24. Aug. 2015. 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. 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
[91096166]
It was reported that during bone grafting of a calcaneus for a tarsal metatarsal fusion on (b)(6) 2017, the instrument used to connect the trephine piece appear to be worn (chips appear on the connecting end of the shaft for trephine attachment). Noticed when the surgical staff was trying to disconnect the piece to get the bone graft out. There was no reported surgical delay. No fragments involved. The procedure was completed successfully with the patient in stable condition. It is unknown how long the device had been in use. The device does not function as intended because it is hard to connect and disconnect. This complaint involves 1 device. Concomitant devices reported: silicone handle quick coupling part 03. 111. 012/ lot 9763175, quantity x 1. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612488-2017-10544 |
| MDR Report Key | 6984160 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-27 |
| Date of Report | 2017-10-04 |
| Date of Event | 2017-10-04 |
| Date Mfgr Received | 2017-11-29 |
| Device Manufacturer Date | 2015-08-24 |
| Date Added to Maude | 2017-10-27 |
| 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 | 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 BETTLACH |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH CH2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH2544 |
| 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 | 2017-10-27 |
| Returned To Mfg | 2017-10-09 |
| Catalog Number | 03.111.030 |
| Lot Number | 9481881 |
| 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 BETTLACH |
| Manufacturer Address | MURACHERSTRASSE 3 BETTLACH CH2544 SZ CH2544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-27 |