MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-16 for HOOK MCO205D 0.3MM 90DEG 165MM LFT ANG manufactured by Integra Microfrance S.a.s..
[93318100]
Integra has completed their internal investigation on november 14, 2017. Results: evaluation of returned device; the hook is broken. The fragment was not recovered. A thorough observation of breakage area did not highlighted material or manufacturing defect. The etching was done with previous technology that was stopped on 2002. Dhr review; unable to review the applicable dhr as the lot no. Was unavailable. Complaints history; no adverse trend - first occurrence of this risk for this device. Conclusion: this device was manufactured before 2002 and no maintenance was performed by the integra service and repair. The age of the instrument and the lack of maintenance let reasonably conclude that this event is not attributable to integra.
Patient Sequence No: 1, Text Type: N, H10
[93318101]
It was reported that the product's hook broke during surgery. The hook was on the device when the surgery began, but it was not there when starting the incision. It was impossible to determine if the hook was in the internal part of the patient's ear. The hook is ferromagnetic and they could not perform a mri.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00143 |
| MDR Report Key | 7038139 |
| Date Received | 2017-11-16 |
| Date of Report | 2017-10-26 |
| Date Mfgr Received | 2017-10-26 |
| Date Added to Maude | 2017-11-16 |
| 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 SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Street | LE PAVILLON |
| Manufacturer City | SAINT AUBIN LE MONIAL 03160 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 03160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HOOK MCO205D 0.3MM 90DEG 165MM LFT ANG |
| Generic Name | PFM11 |
| Product Code | JYL |
| Date Received | 2017-11-16 |
| Returned To Mfg | 2017-11-13 |
| Catalog Number | MCO205D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA MICROFRANCE S.A.S. |
| Manufacturer Address | LE PAVILLON LE PAVILLON SAINT AUBIN LE MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-16 |