MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-06-28 for LUMBAR KERRISON RONGEUR 53-1417 manufactured by Codman & Shurtleff, Inc.
[179058]
Per user facility medwatch report; screws fell out of two kerrisoon rongeurs during surgical procedure. X-rays taken. In phone conversation on 6/8/00, risk manager revealed screw fell out of handle or handles. There was delay of about 30 minutes during which a portable x-ray was set up. X-ray found no screw or screws in site. Pt not adversely affected. Note: during conversation, the risk manager was unsure if one or two rongeurs lost screws during the procedure although the medwatch report refers to two instruments, it is unlikely; however; that screws would fall out of two separate instruments of the same code during one surgical procedure. As such; a medwatch report will be filed for one instrument and a second report will be filed if it is determined that a second instrument was also involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2000-00025 |
| MDR Report Key | 283836 |
| Report Source | 05,06 |
| Date Received | 2000-06-28 |
| Date of Report | 2000-06-28 |
| Date of Event | 2000-05-11 |
| Date Mfgr Received | 2000-06-07 |
| Date Added to Maude | 2000-07-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMBAR KERRISON RONGEUR |
| Generic Name | INSTRUMENT, SURGICAL, MANUAL |
| Product Code | HAD |
| Date Received | 2000-06-28 |
| Model Number | NA |
| Catalog Number | 53-1417 |
| Lot Number | UNK |
| ID Number | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 270442 |
| Manufacturer | CODMAN & SHURTLEFF, INC |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US |
| Baseline Brand Name | LUMBAR KERRISON RONGEUR |
| Baseline Generic Name | INSTRUMENT, SURGICAL, MANUAL |
| Baseline Model No | NA |
| Baseline Catalog No | 53-1417 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-06-28 |