MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-17 for IM REAMER, MOD. TRINKLE FITTING BIXCUT ?10,0X480MM 02276100 manufactured by Stryker Trauma Kiel.
[93077218]
Once the investigation has been completed any additional information will be reported in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[93077219]
It was reported by the biomedical engineer at the hospital that during a total hip surgery performed by dr. (b)(6), the reamer broke when reaming the femur. The procedure was completed successfully by replacing the reamer by a new one.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009610622-2017-00357 |
| MDR Report Key | 7041004 |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-10-25 |
| Date Added to Maude | 2017-11-17 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER TRAUMA KIEL |
| Manufacturer Street | PROF. KUENTSCHER-STRASSE 1-5 |
| Manufacturer City | SCHOENKIRCHEN/KIEL D-24232 |
| Manufacturer Postal Code | D-24232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IM REAMER, MOD. TRINKLE FITTING BIXCUT ?10,0X480MM |
| Generic Name | HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE |
| Product Code | MAY |
| Date Received | 2017-11-17 |
| Catalog Number | 02276100 |
| Lot Number | K024270 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER TRAUMA KIEL |
| Manufacturer Address | PROF. KUENTSCHER-STRASSE 1-5 SCHOENKIRCHEN/KIEL D-24232 D-24232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-17 |