MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for IM REAMER, MOD. TRINKLE FITTING BIXCUT ?10,5X480MM 02276105 manufactured by Stryker Trauma Kiel.
[137055420]
Once the investigation has been completed any additional information will be reported in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[137055421]
The surgeon reported that during the case the 10. 5 flexible reamer was used and the tip broke off leaving a piece in the femoral canal. Attempts were made to remove the piece but were unsuccessful. The case was completed as the piece was sufficiently far down the canal that the implant could still be placed over the top. The surgeon stated that the device is not cannulated and, as a result, it is more difficult to remove the item if it breaks because of this design feature.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009610622-2019-00077 |
| MDR Report Key | 8359063 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-01-25 |
| Date Mfgr Received | 2019-04-02 |
| Device Manufacturer Date | 2018-11-01 |
| Date Added to Maude | 2019-02-21 |
| 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. KEVIN SMITH |
| 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 ?10,5X480MM |
| Generic Name | INSTRUMENT |
| Product Code | MAY |
| Date Received | 2019-02-21 |
| Returned To Mfg | 2019-03-07 |
| Catalog Number | 02276105 |
| Lot Number | K0A176D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-02-21 |