MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-31 for RHOTON-TYPE HOOK 71/2 90D BLT 277269 manufactured by Jarit.
[76501558]
On 5/24/2017 integra investigation completed. Manufacture date unknown. Method: failure analysis, device history evaluation. Results: failure analysis - one rhoto hook returned in used condition, showing minimal wear and a broken tip. Without knowing how much pressure was used to the tip when in use, the cause is undetermined. This type of damage is usually the result from improper usage. The complaint report is confirmed; damaged/worn. Device history evaluation - nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Health hazard engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history/corrections: none. Evaluation history: none. Conclusion: the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[76501559]
Customer initially reports that doctor was performing a adcf using the rhoton hook and felt the tip break off. He searched the patient cavity to find the broken piece and could not find it. He thinks it may have been sucked up by the suction they were using but isn't positive. The rest of the case was completed without additional incidence. On (b)(6) 2017 doctor was performing a cervical 3-7 anterior cervical discectomy fusion. X-ray was taken. No harm done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00059 |
| MDR Report Key | 6601188 |
| Date Received | 2017-05-31 |
| Date of Report | 2017-05-09 |
| Date of Event | 2017-05-08 |
| Date Mfgr Received | 2017-05-09 |
| Date Added to Maude | 2017-05-31 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | JARIT |
| Manufacturer Street | J. JAMNER SURG INST INC. 9 SKYLINE DRIVE |
| Manufacturer City | HAWTHORNE NY 10532 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 10532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RHOTON-TYPE HOOK 71/2 90D BLT |
| Generic Name | N/A |
| Product Code | GZX |
| Date Received | 2017-05-31 |
| Returned To Mfg | 2017-05-16 |
| Catalog Number | 277269 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JARIT |
| Manufacturer Address | J. JAMNER SURG INST INC. J. JAMNER SURG INST INC. HAWTHORNE NY 10532 US 10532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-31 |