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 DOUBLEDRILLGUIDE 3.5/2.5 312.28 312.280-US manufactured by Wrights Lane Synthes Usa Products Llc.
[188673357]
Part: 312. 280. Lot: 2502340. Manufacturing site: bettlach. Release to warehouse date: 01. July 2009. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. Visual inspection: the double drill guide 3. 5/2. 5 (p/n: 312. 280, lot #: 2502340) was returned and received at us customer quality (cq). Upon visual inspection, it was observed that the device was bent. The 2. 5 mm drill bit was observed to be broken and was investigated under a different pi in the same pc. There were scratches on the device but has no impact on the functionality of the device. Device failure/defect identified? Yes. Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage. Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device. Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed. Double drill guide 3. 5/2. 5 dia. Complaint confirmed? Yes, the device received was bent. Hence confirming the allegation. Investigation conclusion the complaint condition is confirmed for the double drill guide 3. 5/2. 5 (p/n: 312. 280, lot #: 2502340). There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined. 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
[188673358]
It was reported that on january 1, 2020, the drill bit broke inside of a drill guide and became stuck. It is unknown if there were fragments generated. Procedure outcome is unknown. There was no patient consequence. Concomitant devices: drill guide (part: 312. 280, lot: 2502340, quantity: 1). This report is for a 2. 5mm drill bit. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01315 |
| MDR Report Key | 9847257 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2009-07-01 |
| 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 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLEDRILLGUIDE 3.5/2.5 |
| Generic Name | GUIDE |
| Product Code | FZX |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-02-20 |
| Model Number | 312.28 |
| Catalog Number | 312.280-US |
| Lot Number | 2502340 |
| 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 | 2020-03-18 |