MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-25 for MANUAL ORTHOPEDIC SURGICAL INSTRUMENT 62380110 manufactured by Wright Medical Technology, Inc..
[121584271]
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[121584272]
Allegedly, it was reported on medwatch mw5078900 that the tips of the rasps broke off into the patients bone during an osteotomy of the left foot. The surgeon was unable to remove the broken portions of the rasp from the patient's bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2018-00148 |
| MDR Report Key | 7905513 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-25 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-08-27 |
| Device Manufacturer Date | 2015-06-12 |
| Date Added to Maude | 2018-09-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MATTHEW PARRISH |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT |
| Generic Name | RASP, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GAC |
| Date Received | 2018-09-25 |
| Model Number | 62380110 |
| Lot Number | 1441712 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-25 |