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 2020-03-12 for ANT BROACH HANDLE - R 2598-07-360 259807360 manufactured by Depuy Orthopaedics Inc Us.
[183152268]
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
[183152269]
It was reported that the patient had a right total hip. During assembly of the instruments after the surgery, it was noticed the offset broach handle was broken. A piece was missing from the locking junction in the middle of the handle. It was unknown where the piece was, or if the piece was left in the patient. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07609 |
| MDR Report Key | 9824105 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2008-01-15 |
| Date Added to Maude | 2020-03-12 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS INC. 1818910 |
| Manufacturer Street | 700 ORTHOPEDICS 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 | ANT BROACH HANDLE - R |
| Generic Name | HIP INSTRUMENTS : HANDLES |
| Product Code | HTQ |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-03-10 |
| Model Number | 2598-07-360 |
| Catalog Number | 259807360 |
| Lot Number | B0108 |
| 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 | 2020-03-12 |