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 2020-01-08 for 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/330MM LENGTH 389.41 manufactured by Wrights Lane Synthes Usa Products Llc.
[174285885]
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. (b)(4). 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
[174285886]
It was reported that on (b)(6) 2019, the screw piece of the laminectomy punch that connects the handle came loose during surgery and fell into the patient. It was not identified until after the implants were secured. Surgeons agreed that it was better left in the patient, which resulted in an intentional retained foreign object. There was a surgical delay of fifteen (15) minutes. Patient status was unknown. Concomitant device reported: unknown implants (part # unknown, lot # unknown, quantity unknown). This report is for one (1) 40 deg up-biting laminectomy punch 4mm width/ 330mm length. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00095 |
| MDR Report Key | 9566099 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-13 |
| Date of Event | 2019-12-08 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2013-09-25 |
| Date Added to Maude | 2020-01-08 |
| 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 | 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/330MM LENGTH |
| Generic Name | PUNCH, SURGICAL |
| Product Code | LRY |
| Date Received | 2020-01-08 |
| Returned To Mfg | 2019-12-24 |
| Model Number | 389.41 |
| Catalog Number | 389.41 |
| Lot Number | T997998 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2020-01-08 |