MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-19 for DEPTH GAUGE FOR 2.7MM & SMALL SCREWS 319.04 manufactured by Wrights Lane Synthes Usa Products Llc.
[188666938]
The complaint device was not received for investigation. The following investigation is based on the image provided in the attachment? 319. 04_depth gauge for 2. 7 mm and 3. 5 mm screws the image was reviewed, and the complaint condition could be confirmed as it can be seen from the images that the needle of the depth gauge broke. Since the device was not returned, a dimensional inspection and a functional test were not able to be performed. During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Device history lot part number: 319. 04. Lot number: 3656844. Manufacturing site: h? Gendorf. Release to warehouse date: 02. Feb. 2011. A manufacturing record evaluation 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
[188666939]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on february 19, 2020, the depth gauge tip broke off the shaft of the measuring device during an orif of an ankle. No surgical delay reported. This report is for one (1) depth gauge for 2. 7mm & small screws. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01368 |
| MDR Report Key | 9855758 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2011-02-02 |
| Date Added to Maude | 2020-03-19 |
| 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 | WERK H |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEPTH GAUGE FOR 2.7MM & SMALL SCREWS |
| Generic Name | GAUGE, DEPTH |
| Product Code | HTJ |
| Date Received | 2020-03-19 |
| Model Number | 319.04 |
| Catalog Number | 319.04 |
| Lot Number | 3656844 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-19 |