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 2020-03-27 for HELICAL BLADE/SCREW EXTRACTOR 03.037.030 manufactured by Wrights Lane Synthes Usa Products Llc.
[185915276]
Investigation summary - investigation flow: damage. Visual inspection: the helical blade/ screw extractor (p/n 03. 037. 030 lot 9354757) was returned and received at us cq. A visual inspection was performed. The distal tip of the device was observed to be broken and the broken part was not returned to us cq. The instrument displayed wear from normal and repeated use and servicing. No other issues were identified with the returned components of the device. Device failure/defect identified? Yes. Dimensional inspection dimensional inspection of the received device was performed at cq. The diameter closer to the distal tip base was intended to be measuring from 2. 7mm +/- 0. 1mm and was measured to be 2. 72 mm (ca215p) which is within specification as per the drawing. Document/specification review based on the date of manufacture related drawings are reflecting the current and manufactured revision were reviewed. Complaint confirmed? Yes. Conclusion: the complaint condition is confirmed for the helical blade/ screw extractor (p/n 03. 037. 030 lot 9354757) as the distal tip was broken and the broken part was not returned. There is no indication that a design or manufacturing issue has caused the breakage 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 history lot: part: 03. 037. 030, lot: 9354757, manufacturing site: (b)(6), release to warehouse date: feb. 20, 2015. 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
[185915277]
It was reported that on an unknown date, during inspection at the sterile processing department (spd), a driving cap, radiolucent insertion handle, helical blade extractor and nail extractor were noted to have an unknown malfunction. The driving cap and the insertion handle where broke at the connection of the two and the helical blade extraction and the exaction nail were both stripped at the threads. There was no patient involvement. This complaint involves three (3) devices. This is report 2 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01566 |
| MDR Report Key | 9889199 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-18 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2015-02-20 |
| 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 |
| 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 | SYNTHES HAEGENDORF GMBH-CN |
| 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 | HELICAL BLADE/SCREW EXTRACTOR |
| Generic Name | ROD,FIXATION,INTRAMEDULLARY |
| Product Code | HSB |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-06 |
| Model Number | 03.037.030 |
| Catalog Number | 03.037.030 |
| Lot Number | 9354757 |
| 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 | 2020-03-27 |