MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX ANKLE TITANIUM 6 HOLE FIBULAR LOCKING PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

The reported event could be confirmed based on information received from the hospital.Customer reported to the sales rep that a non-sterilized variax fibular plate was implanted into the patient.Customer noted that the sterilized plate was not present in the set, therefore sent one of the nurse/staff to obtain one from the cupboard.The non-sterile was taken from the cupboard and this was only realized after insertion and close up.Customer reported directly that the first surgery was completed around 1pm local time and patient was sent to recovery room.The staff realized that non-sterilized plate was implanted, so the patient was brought back to theatre (within 2 hours of initial case).Patient underwent another general anesthesia to remove non-sterilized plate and insert the sterilized plate.The patient is doing well and there have not been reports of infection or adverse events.Based on the given information, the root cause was attributed to be user related.The failure was caused by user error.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling (with the chosen range) 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.Disposition is unknown.

Event Description

Customer reported to the sales rep that a non-sterilized variax fibular plate was implanted into the patient.Customer noted that the sterilized plate was not present in the set, therefore sent one of the nurse/staff to obtain one from the cupboard.The non-sterile was taken from the cupboard and this was only realized after insertion and close up.Revision was carried out whilst the patient was still in theatres and a sterile plate was inserted.

• Brand Name: UNKNOWN VARIAX ANKLE TITANIUM 6 HOLE FIBULAR LOCKING PLATE
• Type of Device: IMPLANT
• 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: 8597232
• MDR Text Key: 144669079
• Report Number: 0008031020-2019-00410
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2019

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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