MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-02-27 for COUNTERSINK FOR 4.5MM CORTEX 310.99 manufactured by Synthes Gmbh.
[16376747]
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 supplement mdr. Manufacturing evaluation reports the sample was received and visual inspection noted the centering pin on the tip was broken off and missing. The broken surface is homogenous indicating material conformity same as the manufacturing records. The breakage is possibly indicative of mechanical overload during usage. A review of the device history record did not show conditions that could have contributed to the reported event. The complaint is invalid from a manufacturing perspective.
Patient Sequence No: 1, Text Type: N, H10
[16555302]
It was reported that the tip of the countersink broke off. Instrument was not used for this case, but when the instrument set was taken to decontamination, the (b)(4) technician found that the tip of the countersink was broken off and missing. It is unknown when the piece was broken and whether it happened during some other surgery, as the spd tech did not notice it at the time of previous reprocessing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2013-10383 |
| MDR Report Key | 3015171 |
| Report Source | 05,07 |
| Date Received | 2013-02-27 |
| Date of Report | 2011-06-08 |
| Date of Event | 2011-06-02 |
| Date Mfgr Received | 2013-01-29 |
| Device Manufacturer Date | 2006-04-01 |
| 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 | COUNTERSINK FOR 4.5MM CORTEX |
| Product Code | HWW |
| Date Received | 2013-02-27 |
| Returned To Mfg | 2011-06-21 |
| Catalog Number | 310.99 |
| Lot Number | 2168157 |
| 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 |