MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-02-03 for UNK - INSERTION INSTRUMENT manufactured by Depuy Mitek Llc Us.
[187760762]
This report is for an unknown. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number are unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Concomitant medical products: unknown. (b)(4). 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187760803]
This is report 1 of 5 for the same event. This report is being filed after the review of the following journal article: dr. Dominik meraner, austria "10 years of arthroscopic latarjet procedure: outcome and complications", indian journal of orthopaedics, volume 53, issue 1, pages 102-110, dr. Dominik meraner, speisinger strasse 109, 1130 vienna, austria. The aim of this study is to evaluate the clinical outcome and complications of the latter procedure, most notably infection rate and nerve damage. Materials and methods: 132 shoulders (106 males/19 females, 68 right/64 left) were included in this retrospective study. Patients were included if treatment was performed for anterior instability and if the patient's instability severity index score was at least 4, or if a revision procedure was performed after a prior unsuccessful arthroscopic or open capsule and labral repair. The devices involved were: depuy mitek latarjet instruments, fms duo, (depuy-synthes), shaver and vapr (depuy-synthes). Complications mentioned in the case report were: hematoma, re-operation, broken k-wire, joint instability.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2020-00418 |
| MDR Report Key | 9659606 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-02-03 |
| Date of Report | 2020-01-22 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-02-03 |
| 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 | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6013142063 |
| Manufacturer G1 | DEPUY MITEK LLC US |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - INSERTION INSTRUMENT |
| Generic Name | UNK - INSERTION INSTRUMENT |
| Product Code | FSM |
| Date Received | 2020-02-03 |
| Catalog Number | UNK - INSERTION INSTRUMENT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |