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 2020-03-14 for 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM 03.130.100 manufactured by Wrights Lane Synthes Usa Products Llc.
[188690147]
Product complaint # (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. A review of the device history record. Device history lot: part number: 03. 130. 100, synthes lot number: u354366. Manufactured by orchid unique. A dhr file from the time of manufacture could not be reviewed because it is not been scanned into tungsten yet. Jde confirmed that the lot was released for sale in february 2020. Device history batch null, device history review that no non-conformances occurred during manufacture. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. Investigation will be updated as applicable. 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
[188690148]
It was reported that on (b)(6) 2020, the surgeon was drilling with a 1. 0 drill bit and after going through the first cortex, the drill bit broke before penetrating the second cortex. The tip of the fluted drill bit approximately 5 mm was retained in the patient. There was no surgical delay. The procedure was successfully completed. Concomitant device reported: unknown drill (part # unknown, lot # unknown, quantity 1). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01278 |
| MDR Report Key | 9832889 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-14 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-14 |
| 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 |
| 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 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM |
| Generic Name | BIT, DRILL |
| Product Code | HTW |
| Date Received | 2020-03-14 |
| Model Number | 03.130.100 |
| Catalog Number | 03.130.100 |
| Lot Number | U354366 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-14 |