MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-21 for SCREW FOR COMPRESSION FORECEPS DIA.4XL40 159740ND manufactured by Newdeal Sas.
[63321260]
It was reported an instrument was implanted by the surgeon. ? The customer confirmed to the customer service representative that the instrument was implanted and did not seem to understand what the issue is.? According to integra kitting department, this instrument is not intended for implantation. It was reported no patient injury is alleged. The instrument remains in the patient.
Patient Sequence No: 1, Text Type: D, B5
[64194579]
Integra completed its internal investigation dec 26, 2016. The investigation included: method: review of device history records. Review of complaint management database for similar complaints. Results: dhr for lot f41l reviewed and no anomalies associated to the incident were observed. The lot was manufactured in july 2012. A review of the complaint system was performed for last (b)(6) years. This is the first incident for similar issue like described in this complaint. (b)(4) tibaxys compression screws ((b)(4)) were sold during last (b)(6) years. The rate failure is rated at (b)(4)%. This is the first incident for the lot f41l. Conclusion: the function of the compression screw is defined in the surgical technique used by the surgeon. A surgical technique is delivered with the tibiaxys system. The surgeon must follow the different steps for the surgery. The incident can be explained by an error during the surgery from the team care.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615741-2016-00067 |
| MDR Report Key | 6193024 |
| Date Received | 2016-12-21 |
| Date of Report | 2016-11-25 |
| Date of Event | 2016-11-09 |
| Date Mfgr Received | 2016-12-26 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2016-12-21 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | NEWDEAL SAS |
| Manufacturer Street | 97 ALLEE ALEXANDRE BORODINE PARC TECH DE LAPORTE DES ALPES |
| Manufacturer City | SAINT PRIEST 69800 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCREW FOR COMPRESSION FORECEPS DIA.4XL40 |
| Generic Name | N/A |
| Product Code | HWD |
| Date Received | 2016-12-21 |
| Catalog Number | 159740ND |
| Lot Number | F41L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEWDEAL SAS |
| Manufacturer Address | 97 ALLEE ALEXANDRE BORODINE 97 ALLEE ALEXANDRE BORODINE SAINT PRIEST 69800 FR 69800 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-21 |