MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-07-16 for ROD PUSHER F/CLICKX 388.352 manufactured by Synthes Gmbh.
[3688406]
Device report from synthes (b)(4) reports an event in taiwan as follows: the tip of the rod pusher broke. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10902814]
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. A review of the device history records was performed and no complaint related issues were found. Subject device has been received and is currently in the evaluation process. Investigation is on going; no conclusion could be drawn.
Patient Sequence No: 1, Text Type: N, H10
[16508818]
Device is for treatment, not diagnosis. The investigation has shown that the tip is indeed broken/cracked on one side of the holding tip. The instrument was analyzed for conformance to print specifications, as well as the device history records were researched. No abnormal findings were identified. The broken surface is homogenous which indicate material conformity to the specification as well. Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances. Note that this is an old and often used instrument. Therefore we have to assume that normal wear and tear has finally led to the breakage of the tip. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-04350 |
| MDR Report Key | 3228638 |
| Report Source | 01,07 |
| Date Received | 2013-07-16 |
| Date of Report | 2013-06-24 |
| Date of Event | 2013-06-22 |
| Date Mfgr Received | 2013-08-13 |
| Date Added to Maude | 2013-10-08 |
| 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 | W. LINDENMUTH |
| 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 | ROD PUSHER F/CLICKX |
| Product Code | HXO |
| Date Received | 2013-07-16 |
| Returned To Mfg | 2013-07-05 |
| Catalog Number | 388.352 |
| Lot Number | 1328370 |
| 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 GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-16 |