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 2019-07-23 for LARGE EX-FIX 11MM CRBN FBR ROD 400MM / MR-CONDITIONAL 394.87 manufactured by Wrights Lane Synthes Usa Products Llc.
[151926167]
Additional device product code: ktt. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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
[151926168]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during an external fixation surgery of a distal femur fracture, the black coating of the connecting carbon fibre rod of the large external fixator peeled off and ended up in the patient's wound. As a result, the impact was there was a need for irrigation of the wound to remove the particles that came from the rod prior to closure was performed. All of the fragments were removed from the patient. It is unknown if there was a surgical delay. Patient outcome is unknown. Concomitant device reported: large combination clamp (part 390. 005, lot# unknown, quantity# unknown). This report is for one (1) large ex-fix 11mm carbon fibre rod 400mm. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-59318 |
| MDR Report Key | 8817415 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-23 |
| Date of Report | 2019-08-14 |
| Date of Event | 2019-06-27 |
| Date Mfgr Received | 2019-09-12 |
| Device Manufacturer Date | 2018-12-20 |
| Date Added to Maude | 2019-07-23 |
| 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 |
| 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 | LARGE EX-FIX 11MM CRBN FBR ROD 400MM / MR-CONDITIONAL |
| Generic Name | APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM |
| Product Code | LXT |
| Date Received | 2019-07-23 |
| Returned To Mfg | 2019-08-01 |
| Model Number | 394.87 |
| Catalog Number | 394.87 |
| Lot Number | H757289 |
| 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 | 2019-07-23 |