MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-22 for RHOTON-TYPE HOOK 71/2 90D SSHP 277268 manufactured by Integra York, Pa Inc..
[22725781]
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
[22725782]
Customer medwatch #5041705 reports surgeon was performing an anterior cervical fusion, he noticed that the instrument (a rhoton dissector) was missing a part of it's tip. X-ray was taken at the end of procedure and was negative for presence of foreign body in the incision site. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
[34338465]
On (b)(6) 2015 integra completed investigation. This hook was manufactured at least 15 years ago. The exact manufacturing date is unknown. Method: failure analysis, device history evaluation. Results: failure analysis - the returned hook showing wear. Upon visually inspecting it is confirmed that the tip is broken. Device history evaluation - nonconforming product report / nonconforming material report history: none. 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 complaint is confirmed: root cause undetermined. No manufacturing deficiency has been found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00043 |
| MDR Report Key | 4938378 |
| Date Received | 2015-07-22 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-02-27 |
| Report Date | 2015-06-26 |
| Date Reported to Mfgr | 2015-06-26 |
| Date Mfgr Received | 2015-08-11 |
| Date Added to Maude | 2015-07-24 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 8006542873 |
| 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 | NA |
| Product Code | GZX |
| Date Received | 2015-07-22 |
| Returned To Mfg | 2015-08-04 |
| 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 | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-22 |