MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS 319.006 manufactured by Wrights Lane Synthes Usa Products Llc.
[188680109]
Part # 319. 006. Synthes lot # 9841071. Supplier lot # na. Release to warehouse date: 24 jun 2015. Manufactured by synthes jennersville. No ncr's were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. Visual inspection: the depth gauge for 2. 0mm and 2. 4mm screws (p/n: 319. 006, lot #: 9841071) was received with the needle component broken from the slider. The transverse fracture of the needle is located at the interface between the needle and slider. The distal portion of the needle was observed to be bent off-axis. No other issues were identified. Device failure/defect identified? Yes. Dimensional inspection: needle diameter = conforming. Document/specification review: -depth gauge for 2. 0/ 2. 4mm screws. -protection sleeve. -needle. Complaint confirmed? Yes. Investigation conclusion: this complaint is confirmed as the needle component was broken from the slider. The transverse fracture of the needle is located at the interface between the needle and slider. The distal portion of the needle was observed to be bent off-axis. No new, unique or different patient harms were identified as a result of this evaluation. There was no indication that a design or manufacturing issue contributed to the complaint. No design issues were observed during the document/specification review. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. 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
[188680110]
It was reported that on february 19, 2020 the depth gauge for screws was broken during sterilization in the sterile processing department (spd). There was no patient involvement. This report is for one depth gauge for 2. 0mm and 2. 4mm screws. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01302 |
| MDR Report Key | 9842214 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2015-06-24 |
| Date Added to Maude | 2020-03-17 |
| 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 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS |
| Generic Name | GAUGE,DEPTH |
| Product Code | HTJ |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-03-02 |
| Catalog Number | 319.006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-17 |