MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10° ANGLE FOR PIP ARTHRO; PIN, FIXATION, SMOOTH

Catalog Number ST0A16P

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 03/12/2014

Event Type  Injury  

Event Description

It was reported that the implant broke patient was revised.The surgeon stated that post surgical protocols were followed and no trauma reported as far as he was made aware.The toe implant was implanted in the second toe for a hammer toe.The screw was implanted in the first toe for a bunion.The 24mm screw was a stryker product and was an anticipated hardware removal.Both devices were implanted at same time.¿.

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Evaluation summary: the reported event that smart toe implant had a breakage after surgery could be confirmed with x-rays and pictures of the explanted device.The breakage occurred within 6 weeks.The surgeon stated that post surgical protocols were followed and no trauma reported as far as he was made aware.However, the patient is in obesity (b)(6) and is (b)(6), which means that his bone quality could not be optimal (osteoporosis).Based on complaint history and previous cases, it has been identified that smart toe implants can break when patient is obese or when patient does not respect postoperative care or when patient keeps an important activity within 6 weeks after surgery.Moreover, a previous statement was provided by our clinical expert on a similar case, his expertise reads: "the smart toe is intended to transfer only reduced loads (e.G.With protective application of a forefoot off-loading shoe) until bone consolidation is confirmed by the follow up x-ray examination (normally after 4 - 6 weeks).Early breakage of a smart toe after such a short period is only possible with immediate postoperative full weight bearing and/or massive acute overloading caused by an acute impact injury (e.G.Caused by an unintended hit).No information concerning the circumstances of the implant breakage has been submitted.Therefore, it is only possible to give a short statement in general." based on the investigation results, this case is classified as patient-related (overloading).Please note that the current op tech reads: "postoperative care: smart toe 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)." [original statement - page 14].Please note that the current ifu reads: "recommendations the size of the implant must be adapted to the patient anatomy." [original statement] "precautions for use 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." [original statements] "factors capable of compromising implantation success.Bone pathology, osteoporosis, bone tumors, systemic or metabolic problems and infectious diseases.Excess weight, intense professional or sporting physical activity that exposes the implant to excessive or repeated loads." [original statements] a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Indications for any material, manufacturing or design related problems were not determined in the investigation.If any further information is provided, the investigation report will be updated.

Event Description

It was reported that the implant broke patient was revised.The surgeon stated that post surgical protocols were followed and no trauma reported as far as he was made aware.The toe implant was implanted in the second toe for a hammer toe.The screw was implanted in the first toe for a bunion.The 24mm screw was a stryker product and was an anticipated hardware removal.Both devices were implanted at same time.".

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10° ANGLE FOR PIP ARTHRO
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3735722
• MDR Text Key: 4222104
• Report Number: 0008031020-2014-00141
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2014

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 Catalogue Number: ST0A16P
• Device Lot Number: F003901PBCG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 04/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2013
• 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: 57 YR
• Patient Weight: 92