MAUDE Adverse Event Report: STRYKER GMBH STRAIGHT PLATE VARIAX FIBULA, 6 HOLE / L84MM; PLATE, FIXATION, BONE

Catalog Number 4020806

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 11/19/2017

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

Patient broke her arm and had to have surgery.The rep gave the doctor the wrong plates.He gave him plates for the angle and these went into her arm.Her arm continued to hurt and in (b)(6) she had x-rays done and it was found that the plates were broken and the plates given to the doctor were for the ankle.

Manufacturer Narrative

The reported event that straight plate variax fibula, 6 hole / l84mm was alleged of 'wrong device used' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided despite multiple attempts.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The instruction for use (v15013 rev aa non active implant ifu ot-ifu-105 rev 4) was reviewed: important information for doctors and operating room staff: this package insert does not include all of the information necessary for selection and use of a device.Please see full labeling for all necessary information! ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.For your information, avail yourself of the training courses and publications offered (e.G.Operative techniques).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 did not indicate any abnormalities.No indications of a design related problem was found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

Patient broke her arm and had to have surgery.The rep gave the doctor the wrong plates.He gave him plates for the angle and these went into her arm.Her arm continued to hurt and in february she had x-rays done and it was found that the plates were broken and the plates given to the doctor were for the ankle.

• Brand Name: STRAIGHT PLATE VARIAX FIBULA, 6 HOLE / L84MM
• Type of Device: PLATE, FIXATION, BONE
• 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: 7346774
• MDR Text Key: 102711615
• Report Number: 0008031020-2018-00182
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

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 Catalogue Number: 4020806
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/16/2018
• Supplement Dates Manufacturer Received: 05/06/2018
• Supplement Dates FDA Received: 05/31/2018
• 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): Other