MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-22 for UNKNOWN FINGER IMPLANT UNK FINGER manufactured by Depuy Orthopaedics, Inc. 1818910.
[103408991]
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
[103408992]
Patient initiated complaint received. Received a voicemail from patient informing about the broken implants of her right hand. She said the middle finger on her right hand is slightly off while the ring finger is completely off this was implanted on (b)(6) 2012. Unable to provide the part and lot number of the products implanted. Currently the patient is wearing splints, she already have 3 splints and waiting for the last one. Patient said, she already spent (b)(6) of the splints alone. Her surgeon wasn't sure on what to do about her case. Apologized and empathized to patient. Explained to her about the authorization letter, this will be sent through mail. There is no revision reported at this time. Doi: (b)(6) 2012 : dor: not revised (right hand). Patient is bilateral, please see (b)(4) (left hand).
Patient Sequence No: 1, Text Type: D, B5
[112493742]
Product complaint # ==> pc-(b)(4). Investigation summary ==> no device associated with this report was received for examination. The investigation could not draw any conclusions regarding the reported event. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. 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
| Report Number | 1818910-2018-55886 |
| MDR Report Key | 7362026 |
| Date Received | 2018-03-22 |
| Date of Report | 2018-03-01 |
| Date Mfgr Received | 2018-03-23 |
| Date Added to Maude | 2018-03-22 |
| 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. 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 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN FINGER IMPLANT |
| Generic Name | FINGER IMPLANT |
| Product Code | KYJ |
| Date Received | 2018-03-22 |
| Catalog Number | UNK FINGER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-03-22 |