MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-08-18 for INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10? ANGLE FOR PIP ARTHRO ST0A16P manufactured by Stryker Gmbh.
[23335268]
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Unk smart toe implant. Device will not be returned.
Patient Sequence No: 1, Text Type: N, H10
[23335269]
It has been reported by the surgeon that after 4 weeks of the implantation of a smart toe implant, the x-ray images reveal that the implants are broken.
Patient Sequence No: 1, Text Type: D, B5
[33303666]
Evaluation summary: the reported incident that intramedullary arthrodesis implant smart toe ii 16mm / 10? Angle for pip arthro was alleged of issue s-12 (implant breakage after surgery) could be confirmed since we received x rays showing the broken device. Based on the currently available information, the root cause can be attributed to a patient related issue. The normal range time for osteosynthesis and bone consolidation is 4 to 6 weeks. It was reported that the breakage was noticed 4 weeks after implantation but the patient is 75 years old; therefore the bone healing time and osteosynthesis period is closer to 6 weeks than 4 weeks in this case. Moreover, the patient has overweight (bmi=28. 2). In this case, the patient should have observed a non-weight bearing period of 6 weeks and should have wait for bone consolidation confirmation by the surgeon. Therefore this case is classified as patient related. Please note that the operative technique reads:? Smarttoe implants are not intended for immediate postoperative weight bearing. Be sure that the postoperative loading of the internal fixation is reduced to a minimum (e. G. With application of a forefoot off-loading shoe) until bone consolidation is confirmed by follow up x-ray examination (normally after 4 - 6 weeks). [pages 5 & 14]? [original statement(s)] please note that the ifu reads:? - the product does not allow the immediate resumption of activity by the patient and is not designed to support an immediate load. Immobilization is necessary during the osteosynthesis. [? ] - it is necessary to inform the patient of the precautions to be taken to ensure the success of the implantation. [... ] factors capable of compromising implantation success. - bone pathology, osteoporosis, bone tumors, systemic or metabolic problems and infectious diseases. - senility, mental illness, abuse of illegal drugs, prescription drugs or alcohol. - excess weight, intense professional or sporting physical activity that exposes the implant to excessive or repeated loads. - risk of conflict with other implants. - risk of articular conflict.? [original statement(s)] a review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. No indications of material, manufacturing or design related problems were found during the investigation.
Patient Sequence No: 1, Text Type: N, H10
[33303667]
It has been reported by the surgeon that after 4 weeks of the implantation of a smart toe implant, the x-ray images reveal that the implants are broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2015-00353 |
| MDR Report Key | 5011190 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-08-18 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-07-21 |
| Date Mfgr Received | 2015-09-29 |
| Device Manufacturer Date | 2015-03-11 |
| Date Added to Maude | 2015-08-18 |
| 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. ROSE HAAS |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10? ANGLE FOR PIP ARTHRO |
| Generic Name | IMPLANT |
| Product Code | LZJ |
| Date Received | 2015-08-18 |
| Catalog Number | ST0A16P |
| Lot Number | J06886 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-18 |