MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-27 for BONE CURETTE-ANGLED/OVAL HEAD 03.605.006 manufactured by Synthes.
[3314153]
(b)(4). The surgeon picked up the curette and noticed the tip was sheared off. Was not used during surgery. How the instrument broke is unknown. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
[10547663]
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. Manufacturing investigation: device history record review - the manufacturing records were reviewed and no complaint related issues were found. Product investigation: the device was returned and the visual inspection of the returned device confirmed the tip was badly deformed. Specification investigation corresponds to doc/drawings and processes at the time of manufacture. Investigation conclusion: too much force was applied to the tip of the instrument causing it to bend and chip. Complaint invalid.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-10062 |
| MDR Report Key | 3015061 |
| Report Source | 05,06 |
| Date Received | 2013-02-27 |
| Date of Report | 2010-12-30 |
| Date of Event | 2010-12-30 |
| Date Mfgr Received | 2013-01-28 |
| Device Manufacturer Date | 2009-05-01 |
| 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 |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN D-78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE CURETTE-ANGLED/OVAL HEAD |
| Generic Name | INSTRUMENTS |
| Product Code | HTF |
| Date Received | 2013-02-27 |
| Returned To Mfg | 2011-01-19 |
| Catalog Number | 03.605.006 |
| Lot Number | T935954 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-27 |