MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-06-05 for LINEAR STRAIGHT BROACH HANDLE 803-03-159 510397 manufactured by Greatbatch Medical.
[76746245]
The complaint sample was not returned to greatbatch for evaluation. Thus, an inspection could not be performed by greatbatch to confirm the reported event. A manufacturing review was completed. The reported lot number for this complaint is part of a field action recall, z-2055-2017. (b)(6). Recall number z-2055-2017 per fda website. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[76746246]
It was reported during an unknown patient procedure that the pin that hold the lever in place fell out while working on the patient. An emergency x-ray was done to ensure that the pins did not fall inside of the patient. Pins were not found in the patient and one was recovered but the other pin was not found. The rep was not sure that the other pin was there to begin with. There was a ten (10) minute surgical delay. The procedure was completed successfully and no adverse events were reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004976965-2017-00066 |
| MDR Report Key | 6610977 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-06-05 |
| Date of Report | 2017-05-12 |
| Date of Event | 2016-11-07 |
| Date Mfgr Received | 2017-05-12 |
| Device Manufacturer Date | 2015-07-02 |
| Date Added to Maude | 2017-06-05 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINEAR STRAIGHT BROACH HANDLE |
| Generic Name | BROACH HANDLE |
| Product Code | HTR |
| Date Received | 2017-06-05 |
| Model Number | 803-03-159 |
| Catalog Number | 510397 |
| Lot Number | 2988946 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-06-05 |