MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-16 for UNKNOWN OTHER PRODUCTS UNK KNEE INSTRUMENT manufactured by Depuy Orthopaedics, Inc. 1818910.
[97551519]
(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
[97551520]
It was reported that the impactor handle broke during implant insertion. No surgical delay. All pieces retrieved.
Patient Sequence No: 1, Text Type: D, B5
[104292943]
Patient Sequence No: 1, Text Type: N, H10
[119481806]
Patient Sequence No: 1, Text Type: N, H10
[120001562]
Investigation summary: conclusion and justification status: the complaint states it was reported that the impactor handle broke during implant insertion. The investigation confirmed that the lever had broken as reported. It should be noted that a field safety notice was issued stating that to reduce the possibility of leaving fragments in patients to adhere to the ifu which include inspecting the instruments to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure the complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis. 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 | 1818910-2018-51275 |
| MDR Report Key | 7193240 |
| Date Received | 2018-01-16 |
| Date of Report | 2017-12-29 |
| Date of Event | 2017-12-29 |
| Date Mfgr Received | 2018-08-30 |
| Device Manufacturer Date | 2014-01-21 |
| Date Added to Maude | 2018-01-16 |
| 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 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN OTHER PRODUCTS |
| Generic Name | OTHER PRODUCTS |
| Product Code | HSZ |
| Date Received | 2018-01-16 |
| Catalog Number | UNK KNEE INSTRUMENT |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-16 |