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 2020-03-25 for TIP FOR DHS?/DCS? IMPACTOR (338.28) 338.26 manufactured by Wrights Lane Synthes Usa Products Llc.
[186753390]
Initial reporter is synthes sales representative picture review: it is neither possible to verify the complaint condition nor does the review allow for any determination of the root cause. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventive action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device history lot: part # 338. 26, synthes lot # ft00233, supplier lot # ft00233, release to warehouse date: 19 dec 2016, supplier: flextronics america llc, 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. 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
[186753391]
Device report from synthes reports an event in canada as follows: it was reported that on february 26, 2020, the dhs impactor was broken during impaction of the dhs plate. Another set was opened to complete the procedure. There was a surgical delay of two (2) minutes. No further information provided. Concomitant device reported: unk - plates: dhs/dcs (part # unknown, lot # unknown, quantity # 1). This report is for one (1) tip for dhs? /dcs? Impactor (338. 28). This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01523 |
| MDR Report Key | 9879851 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2016-12-19 |
| Date Added to Maude | 2020-03-25 |
| 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 | TIP FOR DHS?/DCS? IMPACTOR (338.28) |
| Generic Name | IMPACTOR |
| Product Code | HWA |
| Date Received | 2020-03-25 |
| Model Number | 338.26 |
| Catalog Number | 338.26 |
| Lot Number | FT00233 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-25 |