MAUDE Adverse Event Report: STRYKER GMBH STRAIGHT PLATE VARIAX FIBULA, 7 HOLE / L96MM; PLATE, FIXATION, BONE

Model Number	40-20807
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem 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.Additional information: maude report (mw5075607) was received by stryker t and e and reviewed for the events the patient described.Had repair of broken femur and radius with stryker metal plates on (b)(6) 2017 and on (b)(6) 2018 after having suffered pain and noticed deformity of my arm xrays showed both plates were broken and bones were broken again.Was told by my md that he spoke with stryker rep and he was told that rep had given him the wrong plates and i underwent 2nd surgery on (b)(6).Had broken plates removed and new ones put in place.Have new stainless steel plates.

• Brand Name: STRAIGHT PLATE VARIAX FIBULA, 7 HOLE / L96MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7452123
• Report Number: 0008031020-2018-00312
• Device Sequence Number: 1051919
• Product Code: HRS
• UDI-Device Identifier: 07613252222002
• UDI-Public: (01)07613252222002
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K102282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: 40-20807
• Device Catalogue Number: 4020807
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/23/2018
• 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