MAUDE Adverse Event Report: STRYKER GMBH 2.3 M VARIAX HAND LOCK Z-PLATE,NARROW,13HOLES; PLATE, FIXATION, BONE

Catalog Number	57-15379S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Catalog number is unknown at this time.The device was reported as an unknown gamma pin.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
The variax plate was implanted for metacarpal bone at (b)(6) 2018.The plate was broken at (b)(6) 2018.The patient had no external factors such as falling.Plans to remove and replace the plate in the future.
Additional Manufacturer Narrative
The reported event that 2.3 m variax hand lock z-plate,narrow,13holes was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be patient related.The failure was caused due to possible overload which resulted in the plate breakage.The device inspection revealed the following: the returned 2.3 m variax hand lock z-plate,nar,13 holes is indeed fractured as reported.The close up views, done by the microscope of both returned parts, indicating though that the surfaces are homogenous which again indicates conformity to the given specification.The microscopic investigation revealed that the plate broke in low cycle fatigue mode by exceeding the material strength after a few cycles under partially very high forces (possible overload patient related).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The variax plate was implanted for metacarpal bone at 2018/7/17.The plate was broken at 2018/8/24.The patient had no external factors such as falling.Plans to remove and replace the plate in the future.

• Brand Name: 2.3 M VARIAX HAND LOCK Z-PLATE,NARROW,13HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7899067
• Report Number: 0008031020-2018-00621
• Device Sequence Number: 1312073
• Product Code: HRS
• UDI-Device Identifier: 04546540542311
• UDI-Public: 04546540542311
• Combination Product (Y/N): N
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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 Expiration Date: 03/26/2023
• Device Catalogue Number: 57-15379S
• Device Lot Number: 1000297319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 11/05/2018
• 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