MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS 03.010.072 manufactured by Wrights Lane Synthes Usa Products Llc.
[185542915]
This report was initially submitted on (b)(6) 2020 under manufacturer report number 2939274-2020-00472 with a passed acknowledgment received. When a follow-up report was submitted on (b)(6), 2020 the fda acknowledgement indicated that no initial report had been received. On (b)(6), 2020 it was indicated a new report should be submitted. This repot contains the initial and additional information for the event originally reported on 2939274-2020-00472. Part 03. 010. 072, lot 1593364: manufacturing site: (b)(6). Release to warehouse date: (b)(6) 2006. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. A product investigation was completed: upon visual inspection, the device is missing the ball and spring components. However, there were no signs of breakage on the device. The complaint is being confirmed since the ball bearing and spring are missing and not able to be assembled correctly. Dimensional inspections relevant to this complaint were not performed at due to a definitive finding of a missing. The overall complaint was confirmed as the device is missing the ball and spring components. No definitive root cause could be determined based on the provided information. 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
[185542916]
It was reported on (b)(6) 2020, two (2) depth gauge for locking screws, one does not function with lot number 7869711 and the other lot number 5411870 was broken, and all the three locking bolt measuring devices that were also broken during the reverse logistics audit of the returned device at millstone. There was no patient involvement and no additional information is available. This report is for one depth gauge for locking screws to 100mm for im nails. This is report 1 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01558 |
| MDR Report Key | 9888828 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-01-08 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2006-11-29 |
| Date Added to Maude | 2020-03-27 |
| 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 LOCKING SCREWS TO 100MM FOR IM NAILS |
| Generic Name | GAUGE, DEPTH |
| Product Code | HTJ |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-01-13 |
| Model Number | 03.010.072 |
| Catalog Number | 03.010.072 |
| Lot Number | 5411870 |
| 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 | 2020-03-27 |