MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-08 for RONG SMITH PETERSON STR 9.5" 386160 manufactured by Teleflex Medical.
[62329555]
(b)(4). The device has not been returned for investigation at this time. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[62329556]
Surgeon was doing a right total knee on the patient with hardware removal. They were using a rongeur and the screw in the joint of the instrument fell out into the knee of the patient. The screw was found. The screw and rongeur were removed off the field and placed in a biohazard bag. The screw was inspected to make sure it was full. All scrubbed employees were re-gloved and the case went on. Risk was called and informed of what was going on. The rongeur was placed in the risk bin at the or front desk. The patient's condition is unknown.
Patient Sequence No: 1, Text Type: D, B5
[65839331]
(b)(4). Dhr was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns. No concerns were noted with reference to 386160. A visual inspection of the product involved in the complaint could not be conducted since the product was not returned. Dhr was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns. No concerns were noted with reference to 386160. No confirmed complaints were received in this range with the same issue.
Patient Sequence No: 1, Text Type: N, H10
[65839332]
Surgeon was doing a right total knee on the patient with hardware removal. They were using a rongeur and the screw in the joint of the instrument fell out into the knee of the patient. The screw was found. The screw and rongeur were removed off the field and placed in a biohazard bag. The screw was inspected to make sure it was full. All scrubbed employees were re-gloved and the case went on. Risk was called and informed of what was going on. The rongeur was placed in the risk bin at the o. R. Front desk. The patient's condition is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2016-00356 |
| MDR Report Key | 6155049 |
| Date Received | 2016-12-08 |
| Date of Report | 2016-12-08 |
| Date of Event | 2016-11-14 |
| Date Mfgr Received | 2017-01-12 |
| Date Added to Maude | 2016-12-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RONG SMITH PETERSON STR 9.5" |
| Product Code | EMH |
| Date Received | 2016-12-08 |
| Catalog Number | 386160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-08 |