MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-17 for SIGMA HP UNI TIB CUT BLK LM/RL 2024-40-100 202440100 manufactured by Depuy Orthopaedics Inc Us.
[175498455]
Product complaint #: (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
[188006983]
Product complaint # (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
[188006984]
It was reported that the pin would not pass through cut block. Under additional assessment, it was believed the tolerance of the hole to be too tight or damaged to where the pin would not easily pass through. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-123666 |
| MDR Report Key | 9484244 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-17 |
| Date of Report | 2019-11-26 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2017-03-10 |
| Date Added to Maude | 2019-12-17 |
| 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 | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| 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 | 3 |
| Brand Name | SIGMA HP UNI TIB CUT BLK LM/RL |
| Generic Name | KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES |
| Product Code | HTZ |
| Date Received | 2019-12-17 |
| Returned To Mfg | 2019-12-27 |
| Model Number | 2024-40-100 |
| Catalog Number | 202440100 |
| Lot Number | SO2026604 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-17 |