MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-12-31 for CHISEL HANDLE 399.540 manufactured by Synthes Usa.
[19717748]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: the chisel handle in question is missing a screw. Event discovery was not during a patient procedure. No patient involvement. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19980435]
Device is an instrument and is not implanted or explanted. Per complainant, the device will be returned, but has not yet been received by the manufacturer for review/investigation. Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[28690223]
(b)(4): a manufacturing evaluation was completed: the investigation of the chisel handle shows that the tightening screw is missing. Unfortunately without more information? S we are not able to determine the exact cause which has led to this occurrence. As the tip of the screw is designed in such a way that the fixation screw cannot be unscrewed from the bolt it is likely that too much mechanical force had been applied during use. As the lot number is unknown, we are not able to review the device history record. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2014-15701 |
| MDR Report Key | 4375480 |
| Report Source | 01,05,07 |
| Date Received | 2014-12-31 |
| Date of Report | 2014-12-05 |
| Date of Event | 2014-12-05 |
| Date Mfgr Received | 2015-01-06 |
| Date Added to Maude | 2015-01-16 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES USA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHISEL HANDLE |
| Generic Name | CHISEL, BONE, SURGICAL |
| Product Code | EML |
| Date Received | 2014-12-31 |
| Returned To Mfg | 2015-01-06 |
| Catalog Number | 399.540 |
| 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 USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-31 |