MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-30 for T-COAT MICRO HANDLE KERRISON RONGEUR 2130814BT (NL4252-83T) manufactured by S.u.a. Martin Gmbh &co.kg.
[146484384]
The rongeur was returned without the broken-off tip. Inspection of the device revealed evidence of repair and/or rework by unauthorized third parties: (1) grinding marks were visible in the tip area, diminishing material stability and increasing the risk of breakage; and (2) the screw head had been drilled out, destroying the shank and part of the thread and creating the risk of the remainder of the thread falling out. Review of manufacturing documents showed that the device conformed to specifications at the time of release. Hardness of the returned device was tested and found to conform to specifications.
Patient Sequence No: 1, Text Type: N, H10
[146484385]
While in use on a patient during an ortho-spine procedure, the tip of the device broke off and fell into the patient's body. It was retrieved immediately with surgical pickups under direct visualization. The procedure was completed as planned and the patient was discharged the same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010386-2019-00001 |
| MDR Report Key | 8653002 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-03-26 |
| Date Mfgr Received | 2019-05-01 |
| Device Manufacturer Date | 2018-12-01 |
| Date Added to Maude | 2019-05-30 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARKUS PAULI |
| Manufacturer Street | UHLANDSTRASSE 17 |
| Manufacturer City | RIETHEIM-WEILHEIM, 78604 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78604 |
| Manufacturer G1 | S.U.A. MARTIN GMBH &CO.KG |
| Manufacturer Street | UHLANDSTRASSE 17 |
| Manufacturer City | RIETHEIM-WEILHEIM, 78604 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T-COAT MICRO HANDLE KERRISON RONGEUR |
| Generic Name | MANUAL RONGEUR |
| Product Code | HAE |
| Date Received | 2019-05-30 |
| Catalog Number | 2130814BT (NL4252-83T) |
| Lot Number | XMEI05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S.U.A. MARTIN GMBH &CO.KG |
| Manufacturer Address | UHLANDSTRASSE 17 RIETHEIM-WEILHEIM, 78604 GM 78604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-30 |