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 2018-09-04 for SLIDING CARRIAGE 394.43 manufactured by Wrights Lane Synthes Usa Products Llc.
[119039097]
No patient involvement reported. Date of event is unknown. Device is an instrument and is not implanted / explanted. Product development investigation was completed. Visual inspection of the returned device performed at customer quality (cq) confirmed the condition of two devices being stuck together, which agrees with the reported complaint condition. The two devices were unable to be separated at cq. Therefore, the reported complaint condition is confirmed and was able to be replicated at cq. Relevant drawings were reviewed during this investigation. Based on the etchings on the device, it can be determined that it was made prior to the oldest available drawings for this part in synthes systems. Based on the etchings on the returned device, it can be determined that it was made prior to may 21, 1999. Therefore, it is over 19 years old. No product design issues or discrepancies were observed. Device history records review could not be completed as device was manufactured before 1998. A relevant dimensional inspection could not be performed at cq because the features of interest are not accessible as the two devices were returned stuck together. A definitive root cause for the devices becoming stuck together could not be determined based on the provided information. The most likely cause is over tightening leading to a cross threading situation. This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation. No new, unique or different patient harms were identified as a result of this evaluation. 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
[119039098]
(b)(6) reports following: it was reported that during sterile processing department (spd) inspection on an unknown date, the sliding carriage was noted to be cross threaded and seized on two (2) holding sleeves and a schanz screw blunted trocar. There was no patient involvement. During manufacturing investigation, the condition of two devices being stuck together was confirmed, which agrees with the reported complaint condition. This report is for one (1) sliding carriage. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53574 |
| MDR Report Key | 7841673 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-04 |
| Date of Report | 2018-06-18 |
| Date Mfgr Received | 2018-09-18 |
| Date Added to Maude | 2018-09-04 |
| 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 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| 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 | SLIDING CARRIAGE |
| Generic Name | TRACTION,APPARATUS,NON-POWERED |
| Product Code | HST |
| Date Received | 2018-09-04 |
| Returned To Mfg | 2018-07-10 |
| Catalog Number | 394.43 |
| Lot Number | 2019.2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-09-04 |