MAUDE Adverse Event Report: STRYKER GMBH INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO; PIN, FIXATION, SMOOTH

Catalog Number ST0A19P

Device Problems Device Operates Differently Than Expected (2913); Activation Failure (3270)

Patient Problem Failure of Implant (1924)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a forefoot hammertoe procedure today, my surgeon was using our smart toe ii intermedullary implant for fixation.The implant itself is hospital-owned and kept on-site in a bone freezer.Upon implantation of the smart toe into the patient's 2nd proximal interphalangeal joint, the smart toe failed to expand and open upon reaching body temperature.The implant did not gain any purchase in the bone as a result of not expanding properly and was observed to slide in and out of the hole reamed for insertion.After holding the toe in place with the implant inserted for more than 8-10 minutes to see if it would expand, no such expansion or purchase was gained.The implant was removed, and a second smart toe implant (same size but different lot number) was opened and inserted.Again, the implant failed to expand upon reaching body temperature and no purchase was gained.After several more attempts to get this implant to open and gain bone purchase at the fusion site, it too was removed.In the end, the surgeon was forced to use k-wires to achieve fixation, which was not ideal as the bone was made very porous drilling the hole for the smart toe and all the attempts to insert the implant.Considering all the attempts made to insert the smart toe, the fusion site.As a result of the smart toe failures, the patient now has at least 4 unplanned k-wires protruding from their toes, which will be kept in place for a number of weeks.The case was delayed at least 45 minutes, accounting for 30 minutes spent manipulating and inserting the two failed smart toes.After both were considered a failure, the surgeon spent an additional 15 minutes inserting k-wires to achieve fixation.

Manufacturer Narrative

The reported event that intramedullary arthrodesis implant smart toe ii, 19mm/10¿ angle for pip arthro was alleged of 'no expansion' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to be user related.The failure was caused by a mismanagement of the temperature.When the blood is arrested for a long period, the smart toe can take longer to expand because the temperature of the body is too low.Moreover, it was reported that the device was stored in a bone freezer.Most of the time, bone freezer are way below 0¿c, therefore it might take longer for the device to reach body temperature.A warm sterile solution can be used to bath the phalange and help the device to reactivate shape memory.Please note that the operative technique (st2-st-1_smart_toe_op_tech_2015-7181) reads: ''note: to facilitate the shape memory process, the phalanges can be bathed in a warm sterile solution, between 37¿c (98,6¿f) to 40¿c (104¿f).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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

During a forefoot hammer toe procedure today, my surgeon was using our smart toe ii intermedullary implant for fixation.The implant itself is hospital-owned and kept on-site in a bone freezer.Upon implantation of the smart toe into the patient's 2nd proximal interphalangeal joint, the smart toe failed to expand and open upon reaching body temperature.The implant did not gain any purchase in the bone as a result of not expanding properly and was observed to slide in and out of the hole reamed for insertion.After holding the toe in place with the implant inserted for more than 8-10 minutes to see if it would expand, no such expansion or purchase was gained.The implant was removed, and a second smart toe implant (same size but different lot number) was opened and inserted.Again, the implant failed to expand upon reaching body temperature and no purchase was gained.After several more attempts to get this implant to open and gain bone purchase at the fusion site, it too was removed.In the end, the surgeon was forced to use k-wires to achieve fixation, which was not ideal as the bone was made very porous drilling the hole for the smart toe and all the attempts to insert the implant.Considering all the attempts made to insert the smart toe, the fusion site.As a result of the smart toe failures, the patient now has at least 4 unplanned k-wires protruding from their toes, which will be kept in place for a number of weeks.The case was delayed at least 45 minutes, accounting for 30 minutes spent manipulating and inserting the two failed smart toes.After both were considered a failure, the surgeon spent an additional 15 minutes inserting k-wires to achieve fixation.

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 6668526
• MDR Text Key: 78575806
• Report Number: 0008031020-2017-00380
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: ST0A19P
• Device Lot Number: V07714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 06/26/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2016
• 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): Other
• Patient Age: 47 YR