MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-05 for 3.5MM DRILL BIT/QC/110MM 310.350 manufactured by Synthes Bettlach.
[90106849]
Device used for treatment, not diagnosis. No patient involvement reported. Additional product code: hwe, gra, gff implant and explant dates: device is an instrument and is not implanted/explanted. Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received. Initial reporters phone number: (b)(6). Device history records review was conducted. The report indicates that the: part #310. 350 lot. 2307397. Manufacturing location: (b)(4). Manufacturing date: 13. Nov. 2007. 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
[90106850]
Device report from synthes on an event in (b)(6) as follows: it was reported that on receiving loan set from distributor^orthokit centre specialist checked it and found out that drill is broken. No patient involvement. This complaint involves one part. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612488-2017-10506 |
| MDR Report Key | 6916010 |
| Date Received | 2017-10-05 |
| Date of Report | 2017-09-19 |
| Date Mfgr Received | 2017-11-21 |
| Device Manufacturer Date | 2007-11-13 |
| Date Added to Maude | 2017-10-05 |
| 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 | 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 | 0 |
| Brand Name | 3.5MM DRILL BIT/QC/110MM |
| Generic Name | INSTR,SURGICAL,ORTHO,PNEUMATIC POWERED & ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2017-10-05 |
| Returned To Mfg | 2017-10-09 |
| Catalog Number | 310.350 |
| Lot Number | 2307397 |
| 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 | 2017-10-05 |