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 2020-03-18 for DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS 319.006 manufactured by Wrights Lane Synthes Usa Products Llc.
[188675547]
Synthes employee. Investigation summary : investigation flow: damage. Visual inspection: the depth gauge for 2. 0mm and 2. 4mm screws (part # 319. 006) was received at us cq. The device was received missing its body and protection sleeve components. The returned components did not have a lot number etched so it was not possible to visually confirm the reported device's lot number the needle was received bent right at the mating point between the needle and the slider. After mild physical manipulation during the visual inspection the needle broke off the slider. Device failure/defect identified? Yes; components were missing and the needle was broken. Document/specification review: drawing(s) reviewed: (current & manufactured revisions). Conclusion: the overall complaint was confirmed for the received depth gauge for 2. 0mm and 2. 4mm screws as the device was missing components and its needle was broken. Although no definitive root-cause can be determined the device may have experienced unintended forces. The needle was bent/damaged so severely that light physical touch caused the needle to break off the assembly. 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 history lot: part #319. 006. Synthes lot # h786309. A dhr file could not be reviewed as it has not yet been scanned into tungsten as of feb 03, 2020 , but jde confirmed that the lot was released for sale aug 30, 2019, if a dhr file becomes available in the future, the review (of the dhr) will be revisited. A search in mdd non-conformance module confirmed that no non-conformance occurred during manufacture. 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
[188675548]
It was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that a depth gauge was bent. Another depth gauge was received with missing components. There was no patient involvement. This complaint involves two (2) devices. This is 1 of 1 for report (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01317 |
| MDR Report Key | 9847456 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-08-30 |
| Date Added to Maude | 2020-03-18 |
| 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 | 2020-03-18 |
| Returned To Mfg | 2020-02-06 |
| Model Number | 319.006 |
| Catalog Number | 319.006 |
| Lot Number | H786309 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-18 |