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 2020-03-12 for DRILL STOP 357.405 manufactured by Wrights Lane Synthes Usa Products Llc.
[188844475]
Part # 357. 403, synthes lot # us91162, supplier lot # us91162, release to warehouse date: 03 jun 2008, supplier: orchid unique, no ncr's were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. Visual inspection: the 6. 0 mm/ 10. 0 mm step drill bit cannulated, large qc, tfn (part # 357. 403, lot # us91162, mfg # 03- jun-2008) was received at us customer quality (cq) with no visual defects. There was no sign of a proximal bend. Functional test: a functional test was performed, and the drill stop attached to the proximal end of the step drill bit was unable to be disassembled. The complaint was able to be replicated, therefore the complaint is confirmed. The cutting portion of the reamer is dull to the touch and worn. The complaint of the reamer not being able to fit in the motor could not be confirmed since the motor was not returned. Dimensional inspection: dimensional analysis was within specification based on drawing. Document/specification review: the following drawing(s) was reviewed; 6. 0 mm/ 10. 0 mm step drill bit cannulated, large qc, tfn. Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint. While no definitive root cause could be determined it is possible that the device encountered unintended forces. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. No new malfunctions were observed during the course of this investigation. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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
[188844476]
Device report from synthes, reports an event in (b)(6) as follows: it was reported that on an unknown date, the stepped drill bit in question doesn't fit in the motor since the proximal part is worn out. There is no consequence to the patient. This report is for one (1) drill stop. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01253 |
| MDR Report Key | 9824817 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2008-02-29 |
| Date Added to Maude | 2020-03-12 |
| 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 | BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL STOP |
| Generic Name | GUIDE |
| Product Code | FZX |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-02-27 |
| Model Number | 357.405 |
| Catalog Number | 357.405 |
| Lot Number | 5638320 |
| 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 | 2020-03-12 |