MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-18 for PEDINAIL EXTRACTION ADAPTOR N/A 01-1500-9018 manufactured by Orthopediatrics, Inc.
[188716381]
Reference: (b)(4). Complaint sample was not returned for evaluation. Reported event was not confirmed. Dhr review was unable to be performed as the lot number of the involved device is unknown. Risk management file review was deemed appropriate. Review of the complaint history determined that no further action is required as there were no trends identified. Root cause was unable to be determined.
Patient Sequence No: 1, Text Type: N, H10
[188716382]
It was reported that during a planned intermedullary nail removal, the extractor stripped and alternative instrumentation was used to complete the procedure. A delay of greater than thirty minutes was noted as well as increased patient pain. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2019-00045 |
| MDR Report Key | 9722911 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-18 |
| Date of Event | 2019-07-05 |
| Date Mfgr Received | 2019-07-08 |
| Date Added to Maude | 2020-02-18 |
| 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 | LEIGH JESSOP |
| Manufacturer Street | 2850 FRONTIER DRIVE |
| Manufacturer City | WARSAW, IN |
| Manufacturer Country | US |
| Manufacturer Phone | 2670872 |
| Manufacturer G1 | ORTHOPEDIATRICS, INC |
| Manufacturer Street | 2850 FRONTIER DRIVE |
| Manufacturer City | WARSAW, IN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEDINAIL EXTRACTION ADAPTOR |
| Generic Name | EXTRACTOR |
| Product Code | HWB |
| Date Received | 2020-02-18 |
| Model Number | N/A |
| Catalog Number | 01-1500-9018 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOPEDIATRICS, INC |
| Manufacturer Address | 2850 FRONTIER DRIVE WARSAW, IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-18 |