MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-01-16 for LINEAR STRAIGHT BROACH HANDLE 803-03-159 510397 manufactured by Greatbatch Medical.
[97872711]
The device was returned to integer for evaluation and the reported event was confirmed. The locating pin was broken off of the broach handle and was not returned with the device. It was observed that the locating pin had been welded in place before breaking off. Per print, this locating pin is to be machined as part of the broach handle body, not welded. Manufacturing records were reviewed and there were no discrepancies found which were not already known. Previous to the event date of this complaint, recall z-2055-2017 had been submitted and the supplier has since been removed from the approved supplier list. This device lot falls within the scope of this recall. No further investigation required.
Patient Sequence No: 1, Text Type: N, H10
[97872712]
It was reported during a primary patient procedure that the surgeon performed a final post-operative x-ray of the implantables to conclude the case and discovered a small metal fragment in the patient on the x-ray. The surgeon extracted the head and stem in an attempt to reach the metal fragment for removal. It appeared as if the small fragment had broken off the bottom of the handle during impaction of the implantable stem into the patient's femur. The fragment was removed. There was a ten (10) minute surgical delay reported. The surgery was completed as intended with another suitable device that was available. There were no adverse events reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004976965-2017-00187 |
| MDR Report Key | 7192930 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-01-16 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-12-11 |
| Date Mfgr Received | 2017-12-19 |
| Device Manufacturer Date | 2016-04-26 |
| Date Added to Maude | 2018-01-16 |
| 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 | MR. TONY SINGH |
| Manufacturer Street | 4545 KROEMER ROAD |
| Manufacturer City | FORT WAYNE IN 46818 |
| Manufacturer Country | US |
| Manufacturer Postal | 46818 |
| Manufacturer Phone | 2607557466 |
| Manufacturer G1 | GREATBATCH MEDICAL |
| Manufacturer Street | 4545 KROEMER ROAD |
| Manufacturer City | FORT WAYNE IN 46818 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46818 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2055-2017 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINEAR STRAIGHT BROACH HANDLE |
| Generic Name | BROACH HANDLE |
| Product Code | HTR |
| Date Received | 2018-01-16 |
| Returned To Mfg | 2017-01-10 |
| Model Number | 803-03-159 |
| Catalog Number | 510397 |
| Lot Number | 3287315 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREATBATCH MEDICAL |
| Manufacturer Address | 4545 KROEMER ROAD FORT WAYNE IN 46818 US 46818 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-16 |