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 2020-03-17 for ANGLED ACET INSERTR 9200-10-029 920010029 manufactured by Depuy International Ltd - 8010379.
[188121021]
Product complaint #: (b)(4). Investigation summary: examination of the returned device confirms the complaint of the radel handle cracking. All parts were returned and none were left in the patient. A complaint database search of the provided product code identified similar reports. Due to the lack of any patient harms associated with this failure mode, no further action is required. Continue to monitor via (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
| Report Number | 1818910-2020-08335 |
| MDR Report Key | 9843747 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-01 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2013-12-04 |
| Date Added to Maude | 2020-03-17 |
| 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 | 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 ORHOPAEDICS INC. 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 | 3 |
| Brand Name | ANGLED ACET INSERTR |
| Generic Name | HIP INSTRUMENTS : INSERTION DEVICES |
| Product Code | HWR |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 9200-10-029 |
| Catalog Number | 920010029 |
| Lot Number | PC30387001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY INTERNATIONAL LTD - 8010379 |
| Manufacturer Address | ST. ANTHONY'S ROAD LEEDS LS118DT UK LS11 8DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |