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

Catalog Number ST0A16P

Device Problem Break (1069)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.Additional information was requested and if received will be provided on a supplemental report.Device remains implanted.

Event Description

It was reported by the surgeon that the patient had 2 stryker smart toes break.The breakage was confirmed on x-ray.The broken devices were not explanted.

Manufacturer Narrative

The reported event that intramedullary arthrodesis implant smart toe ii 16mm / 10° angle for pip arthro was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be patient related.The failure was caused by a non-union.The patient x-ray shows 2 broken smarttoe implants in the left foot of the patient: 1 broken smarttoe in the 2nd ray and 1 broken smarttoe in the 3rd ray.Both arthrodesis did not occur and there is no bony consolidation.An internal fixation with smarttoe as well as any kind of internal fixation of small bones (e.G.With k-wires) bears a significant number of risks in the healing period.To a lesser extend these risks are device related.The majority of the risks are caused by poor bone quality, poor blood supply of the fragments poor surgical technique and/or poor patient compliance.Typical risks are: delayed union, non-union, malunion, and pain.Some of these risks may be mild and would not require specific therapeutic measures (s2).Some of them might require specific measures (e.G.Additional bracing in delayed union or non-union), specific medication (e.G.Antiphlogistics and/or analgetics) (s3) or would require unintended revision surgery (e.G.Corrective procedures in the case of malalignment or malunion or revision of a non-union) (s3).Please note that the operative technique (st2-st-1_smart_toe_op_tech_2015-7181) reads: ''precautions: 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).[.] 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).[page 14]'' [original statement(s)] moreover, the instruction for use (v15066 rev b smarttoe xfuse ifu ((b)(4))) 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.'' [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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported by the surgeon that the patient had 2 stryker smart toes break.The breakage was confirmed on x-ray.The broken devices were not explanted.

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5922590
• MDR Text Key: 53748587
• Report Number: 0008031020-2016-00431
• 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: 01/13/2017

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: 10/31/2020
• Device Catalogue Number: ST0A16P
• Device Lot Number: J20890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2015
• 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