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 2016-07-26 for SHAFT FOR TREPHINE ATTACHMENTS 03.111.030 manufactured by Synthes Bettlach.
[50440362]
Device was used for treatment, not diagnosis. Patient weight not provided for reporting. Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. A manufacturing investigation action was conducted. Lot: 9063165, part: 03. 111. 030 manufacturing location: (b)(4), manufacturing date: 19. Sep. 2014. 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
[50440363]
It was reported that during a procedure on (b)(6) 2016, two items from the bone harvest set broke while retrieving bone graft from left proximal tibia. The trephine broke at the phalanges and the cutting piece of the attachment also broke. Surgeon was able to retrieve the broken fragments which were present in the graft that was collected. Surgeon confirmed that no fragments remained in the patient. There was a 10 minute delay to the procedure. Patient is in stable condition. This complaint involves 2 devices. This report is 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612488-2016-10314 |
| MDR Report Key | 5822270 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-26 |
| Date of Report | 2016-07-08 |
| Date of Event | 2016-07-08 |
| Date Mfgr Received | 2016-07-08 |
| Device Manufacturer Date | 2014-09-19 |
| Date Added to Maude | 2016-07-26 |
| 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 | TERRY CALLAHAN |
| 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 | 2016-07-26 |
| Catalog Number | 03.111.030 |
| Lot Number | 9063165 |
| ID Number | (01)10886982072283(10)9063165 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-07-26 |