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

Model Number	40-20806
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	10/30/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
As reported in the maude database by the user facility (report # (b)(4)): "patient brought back to operating room approximately one month after implant for orif right forearm for failed hardware.The six hole plate broke.The patient stated this happened after he did one push up.Initial surgery was uneventful and uncomplicated.".

• Brand Name: STRAIGHT PLATE VARIAX FIBULA, 6 HOLE / L84MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9952850
• Report Number: 0008031020-2020-01264
• Device Sequence Number: 2808074
• Product Code: HRS
• UDI-Device Identifier: 07613252221975
• UDI-Public: 07613252221975
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/13/2020

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: 40-20806
• Device Catalogue Number: 4020806
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 04/13/2020
• 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: Required Intervention