MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-08-25 for LINEAR STRAIGHT BROACH HANDLE 803-03-159 510397 manufactured by Greatbatch Medical.
[83686524]
The complaint sample has not been received by integer for investigation, however the distributor has indicated it will be returned. When it is received, it will be evaluated and a follow-up medwatch 3500a emdr will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83686525]
It was reported during an unknown patient procedure that the pin in the locking mechanism is loose. There was a 10-15 minute surgical delay, however the surgery was completed as intended with another suitable device that was available. No adverse events were reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004976965-2017-00104 |
| MDR Report Key | 6820324 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-08-25 |
| Date of Report | 2017-09-05 |
| Date of Event | 2017-07-24 |
| Date Mfgr Received | 2017-09-05 |
| Device Manufacturer Date | 2013-11-22 |
| Date Added to Maude | 2017-08-25 |
| 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 |
| 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 | 2017-08-25 |
| Returned To Mfg | 2017-08-31 |
| Model Number | 803-03-159 |
| Catalog Number | 510397 |
| Lot Number | 2546224 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-08-25 |