MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-05-24 for COUNTERSINK FOR 3.5MM CORTEX AND 4.0MM CANC BONE SCREWS 310.890 manufactured by Synthes Gmbh.
[3451101]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: after a period of 6 months, it appeared that rust was present on the surface of both new and old instrumentation in the hospital inventory. The facility reported that part # 399. 410 (hammer) exhibited features that may indicate retention of contaminants in the metal of the instrument causing leakage from the molecular fissures during the washing and sterilization process. This is 2 of 4 reports for the same event, complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10742237]
This device is 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. Review of the manufacturing records has been requested.
Patient Sequence No: 1, Text Type: N, H10
[11071713]
Device was used for treatment, not diagnosis. The performed investigation has confirmed that residues and stains are visible on the instruments. The review of the production history revealed that the drill bit, countersink and extraction screw were manufactured in 2012 according to the specifications. Since the hammer does not have a lot number, it is not possible to define the production period, and to verify the manufacture documents. However, the missing lot number is an indication that this item is more than 10 years old. Unfortunately the exact cause of the damage cannot be determined, the residues could be removed partly. According to these findings, it is indicative that the deposits are caused by residues after cleaning and sterilization. A review of the device history records was performed and no complaint related issues were found. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-02359 |
| MDR Report Key | 3129109 |
| Report Source | 01,07 |
| Date Received | 2013-05-24 |
| Date of Report | 2013-04-25 |
| Date of Event | 2013-04-25 |
| Date Mfgr Received | 2013-05-22 |
| Device Manufacturer Date | 2012-08-02 |
| Date Added to Maude | 2013-08-05 |
| 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 | C BALL |
| 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 | COUNTERSINK FOR 3.5MM CORTEX AND 4.0MM CANC BONE SCREWS |
| Generic Name | COUNTERSINK |
| Product Code | HWW |
| Date Received | 2013-05-24 |
| Returned To Mfg | 2013-04-29 |
| Catalog Number | 310.890 |
| Lot Number | 7923808 |
| 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 | 2013-05-24 |