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.
[76739171]
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. Report source distributor (b)(4). Recall number z-2055-2017 per fda website.
Patient Sequence No: 1, Text Type: N, H10
[76739172]
It was reported during an unknown procedure that while using the handle, it broke. There was no 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 | 3004976965-2017-00062 |
| MDR Report Key | 6610727 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-06-05 |
| Date of Report | 2017-05-12 |
| Date of Event | 2016-07-25 |
| Date Mfgr Received | 2017-05-12 |
| Device Manufacturer Date | 2016-01-12 |
| 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 | 3185601 |
| 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 |