MAUDE Adverse Event Report: STRYKER GMBH INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10° ANGLE FOR PIP ARTHRO

Catalog Number ST0A16P

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10° ANGLE FOR PIP ARTHRO
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5011190
• MDR Text Key: 23335268
• Report Number: 0008031020-2015-00353
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: ST0A16P
• Device Lot Number: J06886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 68