MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-11-17 for 4 HOLE PIN CLAMP, BLUE MONOTUBE TRIAX 20MM 5150-3-070 manufactured by Stryker Osteosynthesis Selzach.
[1654012]
On (b)(6) 2010, the patient underwent the surgery with the monotube triax (blue) for femoral distraction osteogenesis. The surgeon was monitoring for the patient. The surgeon confirmed that the screw for the fixation of pin clamp and tube were loose. The screw broke when the surgeon tightened the loose screw with the long handle wrench. The surgeon changed the monotube triax to another monotube triax on (b)(6) 2010. The broken monotube triax (blue) bought and was the second use. The surgeon requested the investigation of the event and the improvement of wrench.
Patient Sequence No: 1, Text Type: D, B5
[8824158]
Additional information has been requested and if received will be provided on a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8031020-2010-00157 |
| MDR Report Key | 1915334 |
| Report Source | 01,07 |
| Date Received | 2010-11-17 |
| Date of Report | 2010-10-29 |
| Date of Event | 2010-10-28 |
| Date Mfgr Received | 2010-10-29 |
| Date Added to Maude | 2012-01-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROSE MINCIELI |
| Manufacturer Street | 325 CORPORATE DR. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER OSTEOSYNTHESIS SELZAH |
| Manufacturer Street | BOHNACKERWEG 1 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4 HOLE PIN CLAMP, BLUE MONOTUBE TRIAX 20MM |
| Generic Name | IMPLANT |
| Product Code | KIT |
| Date Received | 2010-11-17 |
| Model Number | NA |
| Catalog Number | 5150-3-070 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER OSTEOSYNTHESIS SELZACH |
| Manufacturer Address | SELZACH 2545 SZ 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-17 |