MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-09-08 for RHOTON-TYPE HOOK 71/2 90D SSHP 277268 manufactured by Integra York, Pa Inc..
[25229505]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[25229506]
Customer initially reports surgeon was performing an anterior cervical fusion. He noticed that the instrument (a rhoton dissector) was missing a part of its tip. X-ray taken at end of procedure was negative for presence of foreign body in the incision site. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
[27469169]
(b)(4). Integra investigation completed. Manufacture date unknown. Method: failure analysis, device history evaluation results: failure analysis - there is one rhoton-type hook returned in used condition, showing minimal wear. Inspected the hook and the tip is broken off, this is a very delicate instrument and could have happened while in use or even dropped. This complaint is confirmed/root cause undetermined. Device history evaluation - nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: none. Health hazard 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
| Report Number | 2523190-2015-00075 |
| MDR Report Key | 5062384 |
| Report Source | USER FACILITY |
| Date Received | 2015-09-08 |
| Date of Report | 2015-08-24 |
| Date of Event | 2015-02-27 |
| Date Mfgr Received | 2015-09-25 |
| Date Added to Maude | 2015-09-08 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHOTON-TYPE HOOK 71/2 90D SSHP |
| Generic Name | N/A |
| Product Code | GZX |
| Date Received | 2015-09-08 |
| Returned To Mfg | 2015-09-16 |
| Catalog Number | 277268 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-08 |