MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-07-05 for UNKNOWN SHOULDER LOCKING SCREW UNK SHOULDER LOCKING SCREW manufactured by Depuy Orthopaedics Inc 1818910.
[113626481]
(b)(4). 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
[113626482]
Reverse total shoulder replacement, dr. (b)(6), (b)(6) hospital, (b)(6) 2018. During use on a patient, it was found that one of the four prongs on the locking screw driver main body had broken off and when the surgeon was implanting the first (inferior) locking screw, the screw driver broke the head off that particular screw. In this situation, we had to break the rest of the head off the screw to bury it as we were unable to remove it. A replacement screw driver has since been sent up, however, there is a need for and the surgeon has requested to have a spare screw driver on consignment in any case in the future. No ae to patient: 10 minutes delay in surgery. Patient id: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[117566180]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Product complaint #: (b)(4). Investigation summary : the reported event cannot be confirmed due to the product not being returned. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2018-63833 |
| MDR Report Key | 7665023 |
| Report Source | OTHER |
| Date Received | 2018-07-05 |
| Date of Report | 2018-06-06 |
| Date of Event | 2018-01-20 |
| Date Mfgr Received | 2018-08-01 |
| Date Added to Maude | 2018-07-05 |
| 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 | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS INC 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN SHOULDER LOCKING SCREW |
| Generic Name | SHOULDER LOCKING SCREW |
| Product Code | MJT |
| Date Received | 2018-07-05 |
| Catalog Number | UNK SHOULDER LOCKING SCREW |
| 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 ORTHOPAEDICS INC 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-05 |