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 2019-05-14 for ROD CUTTER 388.72 manufactured by Wrights Lane Synthes Usa Products Llc.
[144985506]
The device was not returned. Three photographic images were reviewed by us customer quality investigations. The both cutting surfaces were chipped/broken and possibly bent. The complaint was confirmed. As the device was not returned, an as received dimensional inspection, material review, or drawing review are not applicable. Conclusion: during the investigation, no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the reported event. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Therefore, it has been determined that no corrective and/or preventive action is proposed. Device history: part number: 388. 72, lot number: t165145, (b)(4), release to warehouse date: 15-may-2018. A review of the device history records was performed for the finished device lot number, and no non-conformances were identified. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[144985507]
It was reported that on (b)(6) 2019, the rod cutter was bent/broken while being used at the back table during surgery. The procedure was successfully completed with a two (2) minute surgical delay. There was no patient consequence reported. This report is for one (1) rod cutter this is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-58003 |
| MDR Report Key | 8607837 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-14 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-04-16 |
| Device Manufacturer Date | 2018-05-15 |
| Date Added to Maude | 2019-05-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROD CUTTER |
| Generic Name | CUTTER,WIRE |
| Product Code | HXZ |
| Date Received | 2019-05-14 |
| Model Number | 388.72 |
| Catalog Number | 388.72 |
| Lot Number | T165145 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |