MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-19 for DLC DEPTH GAUGE 227436000 manufactured by Depuy Orthopaedics Inc Us 1818910.
[120974227]
Product complaint # (b)(4). Investigation summary: examination of the returned instrument confirmed the complaint. 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. Depuy orthopaedics, inc. (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
[120974228]
Spring on depth gauge defective. No delay. No patient harm. Patient consequence? :no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2018-69767 |
| MDR Report Key | 7889444 |
| Date Received | 2018-09-19 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-08-06 |
| Date Mfgr Received | 2018-08-27 |
| Device Manufacturer Date | 2015-10-28 |
| Date Added to Maude | 2018-09-19 |
| 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 | 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 1818910 |
| 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 | DLC DEPTH GAUGE |
| Generic Name | HIP INSTRUMENTS : DRILL GUIDES |
| Product Code | HJT |
| Date Received | 2018-09-19 |
| Returned To Mfg | 2018-08-27 |
| Catalog Number | 227436000 |
| Lot Number | AG2018471 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-19 |