MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-20 for ANTHOLOGY INSERTER POSTER HARD 71365705 manufactured by Smith & Nephew, Inc..
[106131913]
Patient Sequence No: 1, Text Type: N, H10
[106131914]
It was reported that an anthology inserter was broken during a revision hip surgery using the redapt stem. The threaded part of the inserter tip broke off flush in the implant inserter/extraction hole and could not be removed so it was left in the implant.
Patient Sequence No: 1, Text Type: D, B5
[117975448]
The associated complaint device was returned and evaluated. A visual examination of the returned anthology inserter indicated that the threaded portion of the inserter has fractured off, confirming the stated complaint. The fractured portion remains in the stem. This device was manufactured in 2012. A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. A clinical analysis indicated that the inserter tip is not intended as an implantable device. However, it was communicated that the tip is retained within the threaded portion of the stem and not within tissue or bone. No patient injury is being reported as a result of the retained tip. No further clinical assessment is warranted. Based on this investigation, the need for corrective action is not indicated. No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary. Should additional information be received, the complaint will be reopened. We consider this investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2018-00784 |
| MDR Report Key | 7448563 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-20 |
| Date of Report | 2018-05-28 |
| Date of Event | 2018-03-22 |
| Date Mfgr Received | 2018-03-22 |
| Date Added to Maude | 2018-04-20 |
| 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 | DR SARAH FREESTONE |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal | HU3 2BN |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTHOLOGY INSERTER POSTER HARD |
| Generic Name | NEUROSURGICAL NERVE LOCATOR |
| Product Code | PDQ |
| Date Received | 2018-04-20 |
| Returned To Mfg | 2018-04-20 |
| Catalog Number | 71365705 |
| Lot Number | 12JM08000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-20 |