MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-04-23 for COMPRESSION/DISTRACTION INSTRUMENT 03.111.021 manufactured by Synthes Gmbh.
[3264896]
It was reported that on an unknown date, during an unknown procedure, a dial on a compression distraction instrument would only move six to eight clicks, and then would stick. There was no patient injury reported. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10739526]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. This report is part of the service and repair documentation remediation. Devices that were received by service and repair have either been repaired and returned to the customer or discarded by synthes, making further product evaluation by manufacturing or engineering impossible. A review of synthes device history records for manufacturing revealed no complaint related issues.
Patient Sequence No: 1, Text Type: N, H10
[10776470]
Device was used for treatment, not diagnosis. Subject device has been received and is currently in the evaluation process. Investigation is on going; no conclusion could be drawn. A review of the device history records for this lot has been requested.
Patient Sequence No: 1, Text Type: N, H10
[11101097]
Subject device was forwarded to service and repair, item was received sticking. Item was not repairable. The cause of the issue is unknown. There are no known ncrs associated with this part and lot number. This item was disposed on (b)(4) 2013. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[26145473]
Additional narrative: device is an instrument and is not an implant/explant. The item was received with the dial only moving six to eight clicks then sticking. A service history of the past three years has been reviewed. No service history review can be performed as this is a lot controlled item.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-01883 |
| MDR Report Key | 3072965 |
| Report Source | 07 |
| Date Received | 2013-04-23 |
| Date of Report | 2013-03-26 |
| Date Mfgr Received | 2014-01-27 |
| Device Manufacturer Date | 2012-12-04 |
| Date Added to Maude | 2013-06-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KUBA ZAROBKIEWICZ |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPRESSION/DISTRACTION INSTRUMENT |
| Product Code | JEC |
| Date Received | 2013-04-23 |
| Catalog Number | 03.111.021 |
| Lot Number | T983737 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-23 |