MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-02-27 for PLIF RECTANGULAR BONE CURETTE 389.124 manufactured by Synthes Gmbh.
[16594593]
It was reported that during a procedure of l5 to s1 fusion, the head of the plif (posterior lumbar interbody fusion) rectangular bone curette broke off while taking out the disc. Surgeon completed the procedure successfully using an angled curette. The pt was unharmed.
Patient Sequence No: 1, Text Type: D, B5
[16671533]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated (b)(4) 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. The sample was returned with the tip broken. Visual inspection noted a breakage site where the wall of the box meets the bottom radius of the box. In addition, the broken edges of the instrument where clean however one edge of the broken tip showed rust-like discoloration which extended towards the inside leg of the box. The reported event is possibly indicative of misuse during operation of the device. A review of the device history records did not show related issues that could have caused the failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-10152 |
| MDR Report Key | 3015263 |
| Report Source | 06,07 |
| Date Received | 2013-02-27 |
| Date of Report | 2011-01-11 |
| Date Mfgr Received | 2013-01-29 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2013-05-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | T MCCARRON |
| 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 |
| Manufacturer City | OBERDORF CH-4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLIF RECTANGULAR BONE CURETTE |
| Product Code | HTF |
| Date Received | 2013-02-27 |
| Returned To Mfg | 2011-01-18 |
| Catalog Number | 389.124 |
| Lot Number | A7IA14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-27 |