MAUDE Adverse Event Report: STRYKER GMBH INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 0° ANGLE FOR PIP ARTHROD; PIN, FIXATION, SMOOTH

Catalog Number	ST016P
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.
Event or Problem Description
It was reported by the risk manager, related to ansm that " arthrodesis on 2nd toe, right and left.The patient has been examined 1 month later : rupture of the 2 implants (x-ray images).No consequence because the arthrodesis is ok.".
Additional Manufacturer Narrative
The reported event that intramedullary arthrodesis implant smart toe ii 16mm / 0° angle for pip arthrod was alleged of 'implant breakage after surgery' could be confirmed, based on provided x-rays.Based on investigation, the root cause was attributed to be patient related.The failure was most likely caused by an early mobilization of the fusion site.A clinical assessment from our clinical consultant was provided: ''the fusion site is ok and the fact that the smarttoe fracture proximally is ok since the fusion is intact.No need to remove implant, this maybe secondary to early motion of the implant in the canal of the proximal implant prior to complete union of the fusion site.'' [original statement(s)] please note that the instruction for use (v15066 rev b smarttoe xfuse ifu (drnot0038)) 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.'' [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 or Problem Description
It was reported by the risk manager, related to ansm that " arthrodesis on 2nd toe, right and left.The patient has been examined 1 month later : rupture of the 2 implants (x-ray images).No consequence because the arthrodesis is ok.".

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 0° ANGLE FOR PIP ARTHROD
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 6184985
• Report Number: 0008031020-2016-00595
• Device Sequence Number: 19089588
• Product Code: HTY
• UDI-Device Identifier: 07613252263333
• UDI-Public: (01)07613252263333(17)210430(10)V19752
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: ST016P
• Device Lot Number: V19752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention