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 Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Customer reported that incorrect implants were found in packaging upon opening the product.This implant was not fitted and a new implant was used with no issues.

Manufacturer Narrative

Correction: section initial reporter health professional.The reported incident could not be confirmed, since the inspection of the device showed that the length of the device is indeed a 19mm and that the part is conform to the manufacturing specifications.Therefore, based on the inspection of the device, we can confirm that there is no mix up, and that the implant is indeed the reference mentioned in the packaging.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.

Event Description

Customer reported that incorrect implants were found in packaging upon opening the product.This implant was not fitted and a new implant was used with no issues.

• 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
• MDR Report Key: 8409347
• MDR Text Key: 138795190
• Report Number: 0008031020-2019-00198
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613252263432
• UDI-Public: 07613252263432
• Combination Product (y/n): N
• PMA/PMN Number: K112197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ST0A19P
• Device Lot Number: Y41468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other