MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-28 for HIP GENERAL OFFSET-30? BROACH HANDLE - LEFT 01.10.10.131 manufactured by Medacta International Sa.
[139072318]
Batch review performed on 25 february 2019: lot 1111995c: (b)(4) items manufactured and released on 10-apr-2018. No anomalies found related to the problem. To date, no other similar event has been reported on this lot.
Patient Sequence No: 1, Text Type: N, H10
[139072319]
During the impaction the ball of the broach handle fell out from the passing hole and the spring was broken, no debris fell in the patient. There was a delay of max. Five minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2019-00097 |
| MDR Report Key | 8377334 |
| Date Received | 2019-02-28 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-01-29 |
| Device Manufacturer Date | 2018-04-10 |
| Date Added to Maude | 2019-02-28 |
| 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 | MR STEFANO BAJ |
| Manufacturer Street | STRADA REGINA |
| Manufacturer City | CASTEL SAN PIETRO, SWITZERLAND 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6874 |
| Manufacturer G1 | MEDACTA INTERNATIONAL SA |
| Manufacturer Street | STRADA REGINA |
| Manufacturer City | CASTEL SAN PIETRO, SWITZERLAND 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HIP GENERAL OFFSET-30? BROACH HANDLE - LEFT |
| Generic Name | SURGICAL INSTRUMENT FOR HIP SURGERY |
| Product Code | LHX |
| Date Received | 2019-02-28 |
| Returned To Mfg | 2019-02-13 |
| Catalog Number | 01.10.10.131 |
| Lot Number | 1111995C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDACTA INTERNATIONAL SA |
| Manufacturer Address | STRADA REGINA CASTEL SAN PIETRO, SWITZERLAND 6874 SZ 6874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-28 |