MAUDE Adverse Event Report: STRYKER GMBH 2.3 M VARIAX HAND LOCK 3-D PLATTE,4X2HOLES; PLATE, FIXATION, BONE

Model Number	57-15392
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available for return, device is still implanted.
Event or Problem Description
The patient reports that on (b)(6) 2019, she was implanted with a stryker variax 3d plate 2.3mm 4x2hole as a result of a corrective osteotomy with bone graft implant on the third metacarpal of the right hand.The patient was urged to avoid pressure and carrying so that the screws would not tear out.In the meantime the plate has bent and a corresponding hump has formed in the back of her hand: 20° plate, 30° bone bend underneath.The patient complains of pain.At the moment no further information is available about the hospital where the implantation was performed on (b)(6) 2019.

• Brand Name: 2.3 M VARIAX HAND LOCK 3-D PLATTE,4X2HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9721594
• Report Number: 0008031020-2020-00464
• Device Sequence Number: 355728
• Product Code: HRS
• UDI-Device Identifier: 07613154496761
• UDI-Public: 07613154496761
• Combination Product (Y/N): N
• Initial Reporter Country: AT
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

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: 57-15392
• Device Catalogue Number: 57-15392
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/18/2020
• 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: Other