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

Catalog Number ST016P

Device Problem Material Rupture (1546)

Patient Problem Failure of Implant (1924)

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

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

Event 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.".

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 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
• 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: 6184985
• MDR Text Key: 62694691
• Report Number: 0008031020-2016-00595
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613252263333
• UDI-Public: (01)07613252263333(17)210430(10)V19752
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: ST016P
• Device Lot Number: V19752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• 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): Required Intervention