MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-08 for HOLDING SLEEVE 85MM FOR MEDIUM DISTRACTOR 395.460 manufactured by Wrights Lane Synthes Usa Products Llc.
[138775278]
Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: reporter is synthes sales consultant. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative 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 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
[138775279]
It was reported that during open reduction internal fixation (orif) of ankle surgery on (b)(6) 2019, the wing nut broke on medium distractor sleeve pin and stuck in sleeve. Fragments were generated and? Removed easily without additional intervention. There was no surgical delay. Procedure was successfully completed. No patient consequence. This report is for one (1) holding sleeve 85mm for medium distractor. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-56881 |
| MDR Report Key | 8404526 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-08 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-03-28 |
| Device Manufacturer Date | 2015-02-02 |
| Date Added to Maude | 2019-03-08 |
| 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 | HOLDING SLEEVE 85MM FOR MEDIUM DISTRACTOR |
| Generic Name | TRACTION,APPARATUS,NON-POWERED |
| Product Code | HST |
| Date Received | 2019-03-08 |
| Catalog Number | 395.460 |
| 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 | 2019-03-08 |