MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-11-21 for DRILL BIT ?1.1 L45/33 2FLUTE 513.030 manufactured by Synthes Usa.
[20358718]
Device report from (b)(4) reports an event in (b)(6) as follows: patient presented with fracture of first metacarpal on the right hand following a traffic accident. The surgeon was drilling the cortical bone and the drill bit did not advance. At the extraction point, it was noted the drill bit was broken.
Patient Sequence No: 1, Text Type: D, B5
[20601182]
Device was used for treatment. Investigation coordinated by synthes (b)(4). Report received indicates the dimensions of the broken drill bit were checked and found to be in compliance with the technical drawings and ao/asif specification. The examination of the raw material testing certificates and the manufacturing papers showed no deviations regarding material analysis, strength and structural stability. The values were in compliance with ao/asif specification and with the international standard. We are not able to determine the exact cause which leads to this occurrence. It is possible that too much mechanical force was applied during the surgery (too high drill speed, hard bone or possible movement in a slanting position). No product fault could be detected. The manufacturing documents were reviewed and no complaint related issues were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-03303 |
| MDR Report Key | 2841828 |
| Report Source | 01,07 |
| Date Received | 2012-11-21 |
| Date of Report | 2012-10-24 |
| Date of Event | 2012-10-20 |
| Date Mfgr Received | 2012-10-24 |
| Device Manufacturer Date | 2012-03-20 |
| Date Added to Maude | 2013-02-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SARMA PIN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL BIT ?1.1 L45/33 2FLUTE |
| Generic Name | DRILL BIT |
| Product Code | HTT |
| Date Received | 2012-11-21 |
| Returned To Mfg | 2012-11-12 |
| Catalog Number | 513.030 |
| Lot Number | F-13135 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-21 |