MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-13 for SIGMA HP UNI TIB CUT BLK RM/LL 2024-40-200 202440200 manufactured by Depuy Orthopaedics Inc Us.
[189085803]
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
[189085804]
I have just been made aware of a headed drill pin that got stuck in the tibial resection guide on (b)(6) 2019. The hospital was unable to remove pin from the guide and has broken after case whilst trying to remove pin from guide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-01642 |
| MDR Report Key | 9582720 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-27 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-02-12 |
| Date Added to Maude | 2020-01-13 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER IN 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | ST. ANTHONY ROAD |
| Manufacturer City | LEEDS 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 RM/LL |
| Generic Name | KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES |
| Product Code | HTZ |
| Date Received | 2020-01-13 |
| Returned To Mfg | 2020-02-04 |
| Model Number | 2024-40-200 |
| Catalog Number | 202440200 |
| Lot Number | SO2041701 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-13 |