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 2019-02-21 for SHAFT FOR TREPHINE ATTACHMENTS 03.111.030 manufactured by Wrights Lane Synthes Usa Products Llc.
[137524591]
A product investigation was conducted. Visual inspection: the shaft for trephine attachments was received with all three (3) distal prongs broken off. The prongs were not returned. The break was roughly transverse and located as the base of the prongs. The balance of the device shows surface wear consistent with use and which would not impact the functionality. The received condition does agree with the complaint description for broken and is confirmed. The cause of the issue could not be determined to be use error, misuse/abuse, noncompliance, postoperative trauma. Dimensional inspection was performed for inner distal and at base of prongs and is conforming as per relevant drawings. Document/specification review: the relevant drawing(s) was reviewed. A device history record could not be conducted as all documents got lost. Memo dated 18 february 2015. Material/hardness review: the material could not be reviewed due to the dhr issue stated above, however the device was manufactured in aug 2013 (5. 5 years old) and based on its age it is believed the material would of contributed to the issue. Investigation conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown. However, the received condition is consisted with exceeding lateral forces potentially form off-axis use or incomplete attachment of the mating attachments. During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition. 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
[137524592]
It was reported that the sterile processing staff noticed that the shaft for trephine attachments was damaged and beyond repair. There was no patient involvement. This report is for one (1) shaft for trephine attachments. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-56574 |
| MDR Report Key | 8358487 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-21 |
| Date of Report | 2018-12-28 |
| Date Mfgr Received | 2019-02-19 |
| Device Manufacturer Date | 2013-08-29 |
| Date Added to Maude | 2019-02-21 |
| 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 | SHAFT FOR TREPHINE ATTACHMENTS |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2019-02-21 |
| Returned To Mfg | 2019-01-10 |
| Catalog Number | 03.111.030 |
| Lot Number | 8507883 |
| 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 | 2019-02-21 |