MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-24 for ROUND HARD DISSECTOR 23275-440 manufactured by Medsorb Dominicana, S.a..
[76042537]
Root cause: the raw material sponge is supplied to deroyal by (b)(4). Therefore, a supplier notification letter was issued to (b)(4). In a response to the letter, (b)(4) indicated a root cause of product misuse. The marketed intended use of the dissector is as follows: "dissection of soft tissue during surgical procedures. " use of the product as an applicator for "bone wax" or any other substance is considered misuse. Corrective action: a corrective action has not been taken at this time due to the root cause. Investigation summary: an internal complaint ((b)(4)) was received reporting that bone wax was not sticking to round hard dissector (part number 23275-440) and the dissector was falling apart in the patient. Representative samples were returned and no issues were found. Inventory inspection was performed and samples from the inspection were stuck to a wrap to try to recreate the failure mode. However, the failure could not be recreated. A lot number was not provided in the initial report. However, the samples received showed a lot number of 42524753. The device history record for this lot number was reviewed and no issues were identified when this work order was produced. The complaint log was reviewed and no related reports were found. (b)(4). During this time period, no similar complaints have been received. The raw material is sponge is supplied to deroyal by (b)(4). Therefore, a supplier notification letter was issued to (b)(4) and a response was received may 19, 2017. Preventive action: trending about this issue will be monitored. The investigation is complete at this time. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[76042538]
Bone wax will not stick to dissector well and it is falling apart while in patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004605321-2017-00002 |
| MDR Report Key | 6588817 |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-24 |
| Date of Event | 2017-04-27 |
| Date Mfgr Received | 2017-04-27 |
| Date Added to Maude | 2017-05-24 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INTERCONTINENTAL, S.R.L. |
| Manufacturer Street | KM 7 AUTOPISTA JOAQUIN BALAGUE PISANO FREE ZONE, BUILDING 49 |
| Manufacturer City | SANTIAGO, SANTIAGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROUND HARD DISSECTOR |
| Generic Name | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDI |
| Date Received | 2017-05-24 |
| Returned To Mfg | 2017-05-10 |
| Model Number | 23275-440 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDSORB DOMINICANA, S.A. |
| Manufacturer Address | ZONA FRANCA INDUSTRIAL SAN PEDRO DE MACORIS SAN PEDRO DE MACORIS DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-24 |