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 2018-09-11 for TREPHINE manufactured by Wrights Lane Synthes Usa Products Llc.
[119815532]
Patient weight is unknown. This report is for an unknown trephine. Part and lot numbers are unknown; udi number is unknown. Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter email address is unknown. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[119815533]
It was reported that on an unknown date in 2009, a pinnacle sector/acetabular cup was implanted. On (b)(6) 2018 the device was removed due to metallosis, osteolysis, wear, and a hole. During the procedure, the tip of the trephine broke off on the head of the 6. 5 pinnacle dome screw. The screw was deeply embedded and could not be backed out with the screwdriver. All broken pieces were retrieved from the patient. There was a surgical delay of 45 minutes. Patient status and procedure outcome are unknown. Concomitant device/s: 6. 5 acetabular screw (part: unknown, lot: unknown, quantity:1), 56 pinnacle sector/acetabular cup (part: unknown, lot: unknown, quantity:1). This report is for an unknown trephine. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53702 |
| MDR Report Key | 7863926 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-11 |
| Date of Report | 2018-08-13 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-08-13 |
| Date Added to Maude | 2018-09-11 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2018-09-11 |
| 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 | 2018-09-11 |