MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,07 report with the FDA on 2014-11-03 for CHISEL manufactured by Depuy Synthes Spine.
[4998025]
International affiliate received a letter from competent authority (b)(4) reporting that at attempting to insert screws, the concomitant device torx-bit (ie. Screwdriver) was overrunning. It wasn? T possible to insert the screw final or remove. The removal was carried out using a fixed rod in the screw head and the screw head broke off. Two screws broke. The existing thread (ie. Threaded screw shank) had to be pierced and chiseled out. This went more instruments to break (reported to be depuy synthes spine chisel, forceps, screw extraction kit, catalog numbers unknown). For the patients one resulted to 90 min. Prolonged surgical time, a higher blood loss and a bone defect. The following mfg. Medwatch reports are being filed for the two broken screws, and the chisel, forceps, and extraction kit that were reported to have been involved in the event: 1526439-2014-12043 - broken screw. 1526439-2014-12044? Broken screw. 1526439-2014-12045? Broken chisel. 1526439-2014-12046? Broken forceps. 1526439-2014-12047? Broken screw extraction kit.
Patient Sequence No: 1, Text Type: D, B5
[12482766]
A follow up report will be filed upon completion of the investigation. 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
[28916867]
The chisel was not returned for evaluation. Review of the device history record and complaint trend analysis could not be performed as the product code and lot number are unknown. Without the sample we are unable to identify the root cause. At this time, the complaint is considered to be closed. The complaint will be reopened if/when the sample is returned for evaluation. 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 | 1526439-2014-12045 |
| MDR Report Key | 4220895 |
| Report Source | 00,01,05,07 |
| Date Received | 2014-11-03 |
| Date of Report | 2014-10-06 |
| Date of Event | 2014-09-29 |
| Date Mfgr Received | 2014-12-01 |
| Date Added to Maude | 2014-11-03 |
| 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 | 3 |
| Manufacturer Contact | ANITA BARNICK |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283583 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHISEL |
| Generic Name | CHISEL, BONE, SURGICAL |
| Product Code | EML |
| Date Received | 2014-11-03 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-03 |